Published: 21 May 2014
Safety Information
Early Warning System - Monitoring Communication
Cook Petite Vital Port, adherence of tubing to the vessel wall leading to complications in explanting the device
21 May 2014
Medsafe has received several reports of complications occurring during the explanting of this type of device from patients at the conclusion of their treatment. The reports relate to the silicone tubing of the port adhering to the vessel wall by a calcium-like deposit.
Calcium-like deposits are a known potential complication associated with implanted ports and indwelling catheters. However, there has been an increase in the number of reports received by Medsafe recently.
As a result of the adherence the explanting surgeon may need to make an additional incision and perform a venous cut-down to free the tubing from the vessel. There are no reported complications for the patient during the time the port is in use. This particular device is used in children and small adults.
Products Affected
| Product name | Sponsor |
|---|---|
| G26510 / CK-IP-S6018, Cook Petite MRI Single Chamber with silicone catheter attached, without introducer set | Obex Medical Ltd |
| G26469 / CK-IP-S5016 Cook Mini Titanium Single Chamber with silicone catheter attached, without introducer set | Obex Medical Ltd |
These are small devices implanted in a patient for short or long-term delivery of fluids or medications to the vascular system or other anatomical region. The device consists of a housing with a self-sealing septum and a catheter connection mechanism. The device may be implanted in various anatomical locations.
Additional Information
No additional information
Regulator Actions
Medsafe is continuing to monitor reports of adverse events relating to this device
Reporting
Consumers and healthcare professionals are encouraged to report problems with medical devices to Medsafe
When reporting an event relating to this type of device, Medsafe requests that information about the dates of implantation and removal, the hospital(s) where the device was implanted and removed, the anatomical location of the implanted device, and where possible, information about the medications delivered via the port.
Medsafe cannot give advice about an individual’s medical condition. If you have any concerns about a medical device Medsafe encourages you to talk to your healthcare professional.
