MAUDE Adverse Event Report: COOK, INC. AMPLATZ EXTRA STIFF PTFE DOUBLE FLEXIBLE WIRE GUIDE; OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number AES-038145-DF

Device Problem Flaked (1246)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2014

Event Type  malfunction  

Event Description

The coating flaked off the amplatz wires.One of the wires is a little more severe than the other.This physician always uses two wires for this procedure.A section of the device did not remain inside the pt's body.The pt did not require any add'l procedures due to this occurrence.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Event is still under investigation.

• Brand Name: AMPLATZ EXTRA STIFF PTFE DOUBLE FLEXIBLE WIRE GUIDE
• Type of Device: OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, dir ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4257685
• MDR Text Key: 17698521
• Report Number: 1820334-2014-00417
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: AES-038145-DF
• Device Lot Number: 5067752
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/12/2014
• Device Age: 1 MO
• Event Location: Hospital
• Date Manufacturer Received: 08/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1