MAUDE Adverse Event Report: WILSON-COOK MEDICAL, INC. ACROBAT 2 CALIBRATED TIP WIRE GUIDE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number 35-260

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2016

Event Type  malfunction  

Event Description

During an ercp, while using the cook acro-35-260; reference#g34265 calibrated tip wire guide, the coating separated on the wire.No harm came to the patient.Vendor rep at bedside and inspected the device.The device was taken by the rep for further evaluation by cook medical.

• Brand Name: ACROBAT 2 CALIBRATED TIP WIRE GUIDE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): WILSON-COOK MEDICAL, INC.; 4900 bethania station road; winston salem NC 27105
• MDR Report Key: 6144698
• MDR Text Key: 61437150
• Report Number: 6144698
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2016

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 Catalogue Number: 35-260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; NO.
• Patient Age: 22 YR
• Patient Weight: 81