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 Flaked (1246)

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

Event Date 09/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation: a review of the complaint history, instructions for us (ifu), manufacturing instructions (mi), quality control (qc), specifications and a visual inspection of the complaint device was conducted for the purpose of this investigation.The wireguide was returned.Visual examination confirms areas in which the blue ptfe coating is missing.Specifications are in place to govern the construction and dimensional requirements along with mi to direct personnel to utilize a magnified eye loop with a light source to inspect the guide for peelings.All qc inspections for tfe peeling is performed 100%.The ifu included with each device 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 tfe separation in this case.There is no evidence to suggest the device was not manufactured to specifications.The appropriate internal personnel have been notified to monitor for similar events.

Event Description

During a cystoscope procedure, the hiwire & bentson wire guides were introduced initially.Afterwards, it was switched from hiwire to amplatz extra stiff for evaluation against another manufacturer's amplatz super stiff wire guide.The blue coating of the wire guide was observed to be shedding on the tower camera view of the ureteral orifice.The wire was removed.No harm to the patient occurred.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 ; 8128294891
• MDR Report Key: 5161555
• MDR Text Key: 28729388
• Report Number: 1820334-2015-00680
• 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
• Report Date: 09/22/2015

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/22/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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