MAUDE Adverse Event Report: COOK INC BIWIRE NITINOL HYDROPHILIC WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number BWS-035150

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 07/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported, initially they started the ureteroscopy with laser lithotripsy procedure using a rigid ureteroscope and then switched to a flexible ureteroscope.As reported, "doctor was back loading angled end of the biwire nitinol hydrophilic wire guide through the flexible ureteroscope when wire got stuck and would not completely backload through scope.He then tried unloading it the other way and could not do that either, using a hemostat, he was able to pull the wire out from the scope.We then noticed the nitinol core of the wire guide was protruding from the wire of the angled end." the cook district manager advised: the wire core was sticking out, so instead of the angled end looking like an l it looked more like a y, the wire did not break apart (separate).Another same device was used to complete the procedure.No adverse events have been reported as a result of the alleged malfunction.

Manufacturer Narrative

Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A review of complaint history was also performed.One used.035 biwire coated wire guide was received.Initial observation of the wire guide confirmed the inner wire is bent and came loose protruding from the coating.A review of complaint history records shows there have been no additional complaints for lot 10890820.This device was returned to the supplier for further investigation.The supplier completed an investigation and provided the following information.The specimen presents an overall length of 147.90cm and a finished diameter of.03185¿ to.03355¿.A gage bushing certified to be.035¿ passed over the length of the specimen with no more effort than the mass of the bushing sliding down the wire shaft unaided, except by gravity.All diameter measurements were acquired with a non-contact, toolmakers scope after allowing the specimen device to become dry after hydrating the specimen device with blood-bank saline.After wiping the wire with blood-bank saline, the specimen was subjected to visual and tactile examination.The specimen coating appears visually and tactilely consistent when examined at 1x ¿ 18 inches, unaided, wet.The angled end of the specimen presents a fracture of both the polymer jacket material and the metallic core wire with a 3.72mm tear along the axis of the wire from the fracture exposing 5.79mm of the metallic core wire.The exposed metallic core wire presents bend damage over the entire exposed length.No material distal of the fractures was returned with the specimen device.Both fractures present indications of ductile, tensile overload.Additionally, the specimen device presents a large radius bend over the distal (fractured angled end) 6.50cm and the proximal (straight end) 6.50cm; consistent with tensile loading of the flexible ends.Microscopically the specimen coating appears to be worn and abraded, consistent with clinical use.Except where noted, the specimen device appears visually and dimensionally correct.A review of the device history records of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested and was determined to be acceptable.At this time, it is not possible to assign a definitive root cause for the event as reported.As indicated in the precautions section of the device instructions for use, ¿manipulation of wire guide requires appropriate imaging control.Use caution not to force or over manipulate the wire guides when gaining access.When using wire guide through a metal cannula/needle, use caution as damage may occur to outer coating.¿ based on the evidence presented by the sample and the information provided by the supporting documentation, clinical and or procedural factors appear to have impacted on the event as reported.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

Event Description

There has been no additional event information received since the initial report was submitted on 19jul018.

• Brand Name: BIWIRE NITINOL HYDROPHILIC WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7702188
• MDR Text Key: 114415342
• Report Number: 1820334-2018-02132
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002461383
• UDI-Public: (01)00827002461383(17)201010(10)10890820
• Combination Product (y/n): N
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/13/2018

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 Expiration Date: 10/10/2020
• Device Catalogue Number: BWS-035150
• Device Lot Number: 10890820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Initial Date Manufacturer Received: 07/03/2018
• Initial Date FDA Received: 07/19/2018
• Supplement Dates Manufacturer Received: 08/10/2018
• Supplement Dates FDA Received: 08/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RIGID AND FLEXIBLE URETEROSCOPE; RIGID AND FLEXIBLE URETEROSCOPE