MAUDE Adverse Event Report: COOK MEDICAL COOK MICRO-PUNCTURE WIRE; GUIDE WIRE 5 FRENCH STIFF

Model Number PART #G07304

Device Problem Wire(s), breakage of (2347)

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

Event Date 02/14/2019

Event Type  malfunction  

Event Description

During a venous thrombectomy, the surgeon, while trying to access the popliteal vein with a micro-puncture wire, the wire sheared off into the extra-vascular tissue.The wire was retained and the patient was later informed.The procedure was completed and the patient left the operating room.Cook medical, the manufacturer was informed by email.

• Brand Name: COOK MICRO-PUNCTURE WIRE
• Type of Device: GUIDE WIRE 5 FRENCH STIFF
• Manufacturer (Section D): COOK MEDICAL; 750 daniels way; bloomington IN 47404
• MDR Report Key: 3704627
• MDR Text Key: 17927521
• Report Number: 3704627
• Device Sequence Number: 1
• Product Code: FBO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/18/2014,03/18/2019

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: PART #G07304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2014
• Distributor Facility Aware Date: 02/14/2014
• Event Location: Other
• Date Report to Manufacturer: 03/06/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR