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	N/A
Medical Device Problem Codes	Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The vital-port vascular access system was implanted on (b)(6) 2017.A mid-catheter leak was detected on (b)(6) 2018.The catheter detached completely and had to be removed from pulmonary artery on (b)(6) 2018.
Additional Manufacturer Narrative
Investigation summary: the complaint device was not returned for a physical examination.The quality engineering department could not perform a physical investigation.Without a physical investigation of the device, a defect or malfunction of the device or manufacturing process is inconclusive.The instructions for use was reviewed and listed as potential adverse events is 'catheter disconnection, fracture and fragmentation.' catheter disconnect/detachment is a known failure mode of the vital port, and is being tracked and trended.This device has been discontinued.The device history record for this lot number was completed, including the manufacturing and quality control activities.All process steps were complete and signed off by trained personnel.There are no signs in the device history record to indicate that this vital port was shipped to the field nonconforming.

• 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: 7517898
• Report Number: 2522007-2018-00015
• Device Sequence Number: 1438392
• Product Code: DWF
• UDI-Device Identifier: 00827002264892
• UDI-Public: (01)00827002264892(17)200831(10)N149167
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IP-S5116W-MPIS-NT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 11/07/2018
• 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