MAUDE Adverse Event Report: COOK MEDICAL TRACER HYBRID WIRE

Lot Number W3653044

Device Problems Detachment Of Device Component (1104); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2016

Event Type  malfunction  

Event Description

During ercp wire striped at the distal end, a piece of plastic cover broke off and ended up in the catheter.The piece was retrieved.No harm to patient.

• Brand Name: TRACER HYBRID WIRE
• Type of Device: TRACER HYBRID WIRE
• Manufacturer (Section D): COOK MEDICAL; bloomington IN 47402
• MDR Report Key: 5479548
• MDR Text Key: 39760031
• Report Number: MW5060739
• Device Sequence Number: 1
• Product Code: OCY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/01/2016

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: No Information
• Device Lot Number: W3653044
• Other Device ID Number: HYB-48015 G22659
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 73