MAUDE Adverse Event Report: COOK COOK 0.18 GUIDE WIRE

Catalog Number RR-18-480

Device Problems Component Missing (2306); Failure to Advance (2524)

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

Event Date 08/12/2016

Event Type  malfunction  

Event Description

Patient was undergoing an ercp.Physician attempted main pancreatic cannulation but was unsuccessful.He then attempted an eus guided ercp, but the wire could not be advanced into duodenal lumen.It was noted after the procedure that the soft tips of the two cook 0.18 guide wires utilized during the procedure were missing.One of the tips was found in the scope during cleaning.The other tip was unable to be found.The physician "thinks" he saw it in the stomach.He did not feel that it would do any harm to the patient.

• Brand Name: COOK 0.18 GUIDE WIRE
• Type of Device: 0.18 GUIDE WIRE
• Manufacturer (Section D): COOK; bloomington IN
• MDR Report Key: 5979983
• MDR Text Key: 55888210
• Report Number: MW5065042
• Device Sequence Number: 1
• Product Code: DQX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/25/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RR-18-480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 66