MAUDE Adverse Event Report: COOK MEDICAL VENOUS CATHETER IVC FILTER

Model Number IGTCFS-65-1-FEM-CELECT-PT

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/14/2017

Event Type  malfunction  

Event Description

Ivc filter sheath had hole/crack near the hub/catheter junction.

• Brand Name: VENOUS CATHETER IVC FILTER
• Type of Device: VENOUS CATHETER IVC FILTER
• Manufacturer (Section D): COOK MEDICAL
• MDR Report Key: 6503092
• MDR Text Key: 73255938
• Report Number: MW5069174
• Device Sequence Number: 1
• Product Code: DTK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2020
• Device Model Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E3539258
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1