MAUDE Adverse Event Report: COOK VASCULAR INC VITAL-PORT DETACHED SILICONE CATHETER WITH INTRODUCER SET TITANIUM INFUSION PORT; LJT SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Brand name: vital-port detached silicone catheter with introducer set titanium infusion port.(b)(4).The 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 customer reported that a port of the vital-port detached silicone catheter had fractured and was not working.When the physician attempted to remove the device, it was found to be broken in pieces.The port was removed in the operating room, but the patient was later taken to interventional radiology to have the catheter removed under fluoroscopy.The port was placed on (b)(6) 2017 and removed on (b)(6) 2017.The device is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
Additional Manufacturer Narrative
Summary of investigation/evaluation: complaint sample was evaluated and the reported event was confirmed through visual inspection.When the device was inspected with increased magnification, it was observed that there was slight bruising on the catheter and the outlet tubing of the port housing was broken off near the weld connection.The dfmeca was reviewed and catheter disconnect is a known failure mode of this device.Review of the complaint history identified that this complaint falls under the scope of a completed internal corrective action plan, which concluded that the failure mode was potentially caused by an improperly made connection.A summary of the investigation has been sent to the complainant.

• Brand Name: VITAL-PORT DETACHED SILICONE CATHETER WITH INTRODUCER SET TITANIUM INFUSION PORT
• Common Device Name: LJT SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 7072142
• Report Number: 2522007-2017-00041
• Device Sequence Number: 1260150
• Product Code: LJT
• UDI-Device Identifier: 00827002508606
• UDI-Public: (01)00827002508606(17)190630(10)N138660
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K913350
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IP-S6113-MPIS-NT
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/03/2017
• Supplement Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 02/08/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention