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

Model Number N/A

Device Problem Material Disintegration (1177)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.(b)(4).The event is currently under investigation.

Event Description

During a ureteroscopy of the right kidney procedure, a cystoscope was used to introduce a cook (b)(4) wire guides.The (b)(4) was switched to a cook amplatz extra stiff for evaluation against another manufacturer's (b)(4) wire guide.The blue coating of wire guide was observed to be shedding on tower camera view at the ureteral orifice.The wire was then removed.No harm to the patient was reported.No additional procedures or intervention was required due to this occurrence.

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history, instructions for use (ifu), manufacturing instructions, quality control, and specifications was conducted during the investigation.The device was not returned to assist in the investigation.There is no evidence to suggest all items in the lot or similar devices in house are nonconforming/defective.The ifu states the following precaution: when using wire guide through a metal cannula/needle, use caution as damage may occur to outer coating." without more specific details of the event, it is not possible to determine root cause of the separation in this case.Key internal personnel have been notified and will continue to monitor for similar events.

Event Description

During a ureteroscopy of the right kidney procedure, a cystosope was used to introduce a cook hiwire & bentson wire guides.The hiwire was switched to a cook amplatz extra stiff for evaluation against another manufacturer's amplatz super stiff wire guide.The blue coating of wire guide was observed to be shedding on tower camera view at the ureteral orifice.The wire was then removed.No harm to the patient was reported.No additional procedures or intervention was required due to this occurrence.

• Brand Name: AMPLATZ EXTRA STIFF PTFE FIXED CORE WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5114193
• MDR Text Key: 27145038
• Report Number: 1820334-2015-00666
• 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: Followup
• Report Date: 09/24/2015

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: AES-035145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/24/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2015
• 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
• Patient Weight: 136