MAUDE Adverse Event Report: COOK, INC. AMPLATZ EXTRA STIFF STRAIGHT GUIDEWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number THSF-35-260-AES-BH

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Information (3190)

Event Date 07/19/2014

Event Type  malfunction  

Event Description

Physician requested an amplatz extra stiff wire and noticed a defect in the wire - something was poking out of the wire like the wire was getting undone.It was not used and a second wire was obtained and used.

• Brand Name: AMPLATZ EXTRA STIFF STRAIGHT GUIDEWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK, INC.; 750 daniels way; p.o. box 489; bloomington IN 47404
• MDR Report Key: 4071113
• MDR Text Key: 4813888
• Report Number: 4071113
• Device Sequence Number: 1
• Product Code: OCY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 08/13/2014

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: Invalid Data
• Device Model Number: THSF-35-260-AES-BH
• Device Catalogue Number: G03373
• Device Lot Number: 3516669
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/02/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2014
• Patient Sequence Number: 1