MAUDE Adverse Event Report: COOK, INC. HIWIRE NITINOL WIRE GUIDE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number HWS-035150

Device Problems Peeled/Delaminated (1454); Physical Resistance (2578)

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

Event Date 01/06/2016

Event Type  malfunction  

Event Description

Doctor inserted the guidewire in the cystoscope, felt resistance in advancing the guidewire, he pulled the guidewire out of the scope and found that the guidewire coating appeared to be flaking off.

Manufacturer Narrative

The following elements have blank data.Device model #: for type of device: endoscopic guidewire, gastroenterology-urology unique device identifier (udi): for type of device: endoscopic guidewire, gastroenterology-urology.

Event Description

Doctor inserted the guidewire in the cystoscope, felt resistance in advancing the guidewire, he pulled the guidewire out of the scope and found that the guidewire coating appeared to be flaking off.

• Brand Name: HIWIRE NITINOL WIRE GUIDE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK, INC.; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5737948
• MDR Text Key: 47807462
• Report Number: 5737948
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/25/2016

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: Physician
• Device Model Number: HWS-035150
• Device Catalogue Number: HWS-035150
• Device Lot Number: 10607841
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/25/2016
• Device Age: 0 DY
• Event Location: Other
• Date Report to Manufacturer: 05/25/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR