MAUDE Adverse Event Report: COOK VASCULAR INC VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT; DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number	IP-S5116W-MPIS-NT
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
A mini port placement was performed on (b)(6) 2014 on a female patient who had the pre-existing condition of breast cancer.There was catheter migration after a rupture of the catheter proximally 10 cm after the connection with the reservoir.The user facility removed the catheter and mini port on (b)(6) 2016.The piece of the catheter that had migrated was removed under fluoroscopy.The user facility removed the catheter and mini port on (b)(6) 2016.The piece of the catheter that had migrated was removed under fluoroscopy.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation.A review of complaint history, dimensional verification, device history and visual inspection of the returned device was conducted during the investigation.Visual inspection confirmed that the catheter fractured into two fragments approximately 10.5 cm distal from the vital port body and confirmed the presence of burnishing around approximately one third of the catheter.Burnishing was observed on both catheter fragments.A cut was observed on the proximal end of the ~10.5 cm length of catheter.The cut was perpendicular to the length of the catheter and penetrated approximately halfway through the diameter of the catheter.No other holes, nicks, or abrasions were observed on the catheter.Burnishing and wear were present at the fracture site, no tool marks or punctures were observed on the catheter, the device shows signs of long-term wear.The device fractured due to long-term wear on the catheter, though the cause of the wear is unknown.There are no signs this device was not manufactured to current specifications.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.
Event or Problem Description
A mini port placement was performed on (b)(6) 2014 on a female patient who had the pre-existing condition of breast cancer.There was catheter migration after a rupture of the catheter proximally 10 cm after the connection with the reservoir.The user facility removed the catheter and mini port on (b)(6) 2016.The piece of the catheter that had migrated was removed under fluoroscopy.The user facility removed the catheter and mini port on (b)(6) 2016.The piece of the catheter that had migrated was removed under fluoroscopy.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT
• Common Device Name: DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 5666053
• Report Number: 1820334-2016-00355
• Device Sequence Number: 180468
• Product Code: DWF
• UDI-Device Identifier: 00827002264892
• UDI-Public: (01)00827002264892(17)150731(10)N107328.7
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K931586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: IP-S5116W-MPIS-NT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/03/2016
• Device Age: 46 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2016
• Supplement Report FDA Received Date: 06/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention