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

Model Number G30473

Device Problems Peeled/Delaminated (1454); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: urology coordinator.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, during a ureteroscopy procedure using a hiwire nitinol hydrophilic wire guide, the coating was stripped off.The surgeon has no issue advancing the wire into the ureteroscope.When it was time to pull the wire out of the scope, the user had to forcefully pull back on the wire.This caused the nitonol to strip off from the wire.No adverse events have been reported as a result of the alleged malfunction.Additional details have been requested regarding the patient and event.At this time no additional information has been provided.

Manufacturer Narrative

Investigation/evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, specifications, the instructions for use, and quality control data.One device was returned for investigation.The returned packaging confirms the reported complaint device lot number.The wire guide was received inside the coiled holder.The holder showed signs of hydration.The wire slipped easily out of the protective coil during investigation.The jacket on the wire guide was severed approximately 41.1cm from the distal tip with 6mm of bare wire exposed.The jacket starts to accordion 39.3cm with the accordioned area that measures 3mm in length.A review of the device history record (dhr) found no non-conformances.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there were no non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of the device master record shows sufficient controls are in place to ensure device functionality and integrity prior to distribution.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: end hole size and length of the device must be taken into consideration to ensure proper fit between wire guide and device.Instructions for activating hydrophilic coating for optimal performance, rehydrate the hydrophilic coated wire guide after exposure to ambient environment or after extended use, replace it with a new hydrophilic coated wire guide.The returned complaint device was found to have damage to the polymer jacket.The polymer jacket had been severed along the length of the wire but had not detached from the wire.The wire itself was still intact.Since the user had no issues placing the device through the scope that was being used, it can be concluded that the scope was the appropriate size for the wire guide.The most likely cause for the damage to the wire guide is unintended use error.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information was received 05nov2019: no unintended section of the device remained inside the patient's body.No additional procedures were required due to this occurrence.There was no medical or surgical intervention required due to this occurrence.

• Brand Name: HIWIRE 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: 9249652
• MDR Text Key: 176664147
• Report Number: 1820334-2019-02712
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002304734
• UDI-Public: (01)00827002304734(17)220609(10)11155198
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2022
• Device Model Number: G30473
• Device Catalogue Number: HW-038150
• Device Lot Number: 11155198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 10/30/2019
• Supplement Dates FDA Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS SEMI-RIGID URETEROSCOPE MR6A