MAUDE Adverse Event Report: COOK MEDICAL ERCP GUIDEWIRE

Lot Number W3610416

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 02/16/2016

Event Type  malfunction  

Event Description

During the procedure, md noticed the covering on the wire had separated from the wire.No patient harm.

• Brand Name: ERCP GUIDEWIRE
• Type of Device: GUIDEWIRE
• Manufacturer (Section D): COOK MEDICAL; bloomington IN 47402
• MDR Report Key: 5479528
• MDR Text Key: 39746180
• Report Number: MW5060729
• 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: Health Professional
• Device Expiration Date: 08/10/2018
• Device Lot Number: W3610416
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 127