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

Model Number	G26489
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Event is currently under investigation.A follow up repot will be submitted upon receipt of additional information or completion of investigation.
Event or Problem Description
It was reported that the patient had an infusion port implanted on (b)(6) 2017.When the patient returned three weeks post-op for treatment, the nurses were unable to get blood return and sent the patient for a portogram.The portogram showed that the catheter had separated from the port hub and was in the pulmonary artery.Surgical intervention was required to retrieve the piece and was successfully completed on (b)(6) 2017.The manufacturer was not informed of event until 06dec2017.According to the initial reporter, the patient did not experience any additional adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation summary: there were two similar ports devices returned for this complaint, however the one associated with complaint was not identified.Quality engineering and engineering department performed an investigation on two catheters, two port housings.The catheter locks were not returned for this complaint.The catheters were returned in one piece.There was no evidence of bruising or signs that the catheter was pushed over the port outlet tube ring, no calcification or damage present on the catheter surfaces.There were needle marks evident on the port housings.The device history record was reviewed, including the manufacturing and quality control activities.All process steps were complete and signed off by trained personnel.There is no indication in the device history record that the vital port was shipped to the field nonconforming.The complaint was not confirmed and the root cause of this complaint is inconclusive.

• 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: 7164987
• Report Number: 2522007-2017-00054
• Device Sequence Number: 72935
• Product Code: DWF
• UDI-Device Identifier: 00827002264892
• UDI-Public: (01)00827002264892(17)191130(10)NF142326
• Combination Product (Y/N): N
• PMA/510(K) Number: K931586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2018

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 Model Number: G26489
• Device Catalogue Number: IP-S5116W-MPIS-NT
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 04/30/2018
• 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