MAUDE Adverse Event Report: COOK INCORPORATED MICROPUNCTURE; INTRODUCER, CATHETER

Model Number G43872

Device Problems Break (1069); Entrapment of Device (1212); Unraveled Material (1664)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/03/2023

Event Type  malfunction  

Event Description

Patient in interventional radiology for a placement of hd catheter.During removal portion of procedure, the wire tip became unraveled.Spot imaging was obtained which demonstrated a knot at the tip of the distal end of the micro puncture catheter.Approximately 2 cm of wire tip was broken off and into the soft tissue of patient's neck.Surgery called to bedside and a cut down was performed and they were able to get about 1cm piece of the wire.Team decision to intentionally leave the remnant piece as the risk for removal outweighed the benefit.Cook medical micropunture introducer set.Ref# g43872.Lot# 15252955.

• Brand Name: MICROPUNCTURE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 16760910
• MDR Text Key: 313498980
• Report Number: 16760910
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/05/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: G43872
• Device Catalogue Number: MPIS-505-SST
• Device Lot Number: 15252955
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20075 DA
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Race: Black Or African American