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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2020

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

As reported, during a flexible ureteroscopy and using a hiwire nitinol hydrophilic wire guide, the coating on the tip of the wire guide peeled off.After normal saline was injected, the user had difficulty removing the guidewire and discovered the tip coating had peeled off.The user changed to another brand of guide wire to complete the procedure.No adverse effects were reported due to the alleged malfunction.

Manufacturer Narrative

Event summary: as reported, during a flexible ureteroscopy and using a hiwire nitinol hydrophilic wire guide, the coating on the tip of the wire guide peeled off.After normal saline was injected, the user had difficulty removing the guidewire and discovered the tip coating had peeled off.The user changed to another brand of guide wire to complete the procedure.No adverse effects were reported due to the alleged malfunction.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, manufacturing instructions and quality control procedures and a visual inspection of the device were conducted during the investigation.The device was returned and sent to the device supplier for additional investigation.The device presented a ductile/tensile overload fracture of the polymer jacket with material removal, exposing the distal 0.55cm of the metallic core wire.The device also presented a large radius bend over the distal 9.80cm, consistent with tensile loading.After flushing the dispenser assembly with saline, the device was easily removed from the dispenser assembly with no more effort than grasping the distal end of the wire and pulling it from the unrestrained dispenser.The damage presented by the returned device appeared consistent with attempting to remove the device from the dispenser assembly without hydrating the wire according to the ifu.The instructions for use provided with the device state, ¿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.¿ a review of the device history records conducted by the supplier did not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.During manufacturing the production operators are instructed to 100% visually and tactilely inspect for any obvious defect, which includes a tactile examination of the entire length of each wire.In addition, during packaging of this product the operators are instructed to 100% visually inspect for any obvious defect prior to shipment.The investigation supplier concluded that the product met specification at the time of shipment.The supplier was unable to assign a definitive root cause for the event as reported.A document-based investigation evaluation was also performed by cook.No related non-conformances were recorded.One additional complaint from the product lot was received from the same customer alleging a similar failure mode.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.Based on available evidence, cook has concluded that a cause for the event could not be determined.Cook will continue monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 10993284
• MDR Text Key: 223786405
• Report Number: 1820334-2020-02282
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002304741
• UDI-Public: (01)00827002304741(17)230122(10)11209197
• 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: 03/26/2021

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: 01/22/2023
• Device Model Number: G30474
• Device Catalogue Number: HWS-035150
• Device Lot Number: 11209197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/11/2020
• Supplement Dates Manufacturer Received: 03/16/2021
• Supplement Dates FDA Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR