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

Model Number G30474

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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 an unspecified procedure using a hiwire nitinol hydrophilic wire guide, the coating of the wire guide peeled off.The device issue was discovered prior to the procedure during the preparation stage.Therefore, there was no use on the patient.The procedure was completed by using another same type device.No adverse effects have been reported due to the alleged malfunction.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Ec method code desc - 5: communication/interviews (4111).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, the instructions for use, dimensional verification, specifications, and quality control data.One device was returned for investigation.Visual examination confirmed the wire guides were returned in prior to use condition.The holder was dry and showed no signs of hydration.The wire guide was protruding from the coiled holder by approximately 10cm.The inner metal wire was protruding 5mm from the distal end of the jacket that covers the wire.The jacket appeared cut/severed exposing the wire from the jacket cover.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: 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.When exchanging or withdrawing an instrument over the wire guide, secure and maintain the wire guide in place under fluoroscopy in order to avoid unexpected wire guide displacement.These wire guides are not intended for tpca use.Instructions for activating hydrophilic coating: the hydrophilic coating on the wire guide is activated by immersion in sterile water or sterile saline solution.1.Prior to using the wire guide, fill a syringe with sterile water or sterile saline solution and attach it to the flushing port on the wire guide.2.Inject enough solution to wet the wire guide surface entirely.This will activate the hydrophilic coating.Hydrophilic coated wires are very slippery when wet.Always maintain control of the wire guide when manipulating it through any device.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 supplier was notified of this occurrence and asked to perform an investigation.The supplier's investigation was unable to confirm that the product did not meet specification prior to shipment.The investigation concluded that the product met specification at the time of shipment.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided and the evidence presented, it appeared that handling and/or procedural factors have contributed to the event as reported.The returned wire guide was found to have 5mm of exposed wire on the distal end of the wire guide.The device was returned to the supplier for evaluation.The supplier's manufacturing instructions require operators to visually and tactile inspect for any obvious defect, which includes a tactile examination of the entire length of the wire.The supplier's 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 at lake region medical and was determined to be acceptable.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided and the evidence presented, it appeared that handling and/or procedural factors have contributed to the event as reported.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database 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

No new patient or event information since the last report was submitted.

• 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: 9437837
• MDR Text Key: 184759568
• Report Number: 1820334-2019-03043
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002304741
• UDI-Public: (01)00827002304741(17)220721(10)11165881
• Combination Product (y/n): N
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

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: 07/21/2022
• Device Model Number: G30474
• Device Catalogue Number: HWS-035150
• Device Lot Number: 11165881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1