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

Model Number G30474

Device Problem Material Separation (1562)

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

Event Date 12/17/2020

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

It was reported, before the start of an unspecified endoscopic urology procedure, upon opening an hiwire nitinol hydrophilic wire guide, the user noticed that the tip looked "divided (fringed)".The device was removed from the operating room table.The issue with this device was discovered prior to making contact with the patient and it was not used.It is unknown how the procedure was completed.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.

Event Description

Additional information was received 18mar2021.The device was successfully completed with another device of the same type.

Manufacturer Narrative

Event summary: it was reported, before the start of an unspecified endoscopic urology procedure, upon opening an hiwire nitinol hydrophilic wire guide, the user noticed that the tip looked "divided (fringed)".The device was removed from the operating room table.The issue with this device was discovered prior to making contact with the patient and it was not used.The procedure was completed with another device of the same type.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.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 for investigation and sent to the device supplier for evaluation.The distal 0.35cm of the metallic core wire was protruding through the polymer jacket material 0.40cm from the distal tip.The polymer jacket material over the distal 1.50cm presented indications of ductile tensile loading (stretching).No polymer jacket material was missing.The device also presented a large radius bend over the distal 8.50cm, consistent with tensile loading.A review of the device history records conducted by the supplier did not present any indication of a manufacturing defect or anomaly that could have impacted 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 history records indicated this product was final inspection tested by the supplier and was determined to be acceptable.The damage presented by the returned device appeared consistent with attempting to remove the specimen wire from the dispenser assembly without hydrating the wire as described in the ifu.Based on the information provided and the evidence presented, the supplier concluded that procedural factors contributed to the event as reported.A document-based investigation evaluation was also performed by cook.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.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.The device is provided with instructions for use which provide the following instructions for activating the 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.The complaint device was forwarded to the supplier for evaluation.The supplier investigation notes that 0.35 cm of the metallic core of the guide wire was exposed.A review of the supplier¿s device history returned no anomalies, and the supplier was therefore was unable to determine a definitive root cause for the failure.However, the supplier notes that the failure occurrence appeared consistent with attempted removal of the wire with insufficient lubrication.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.

• 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: 11086915
• MDR Text Key: 227013004
• Report Number: 1820334-2020-02366
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002304741
• UDI-Public: (01)00827002304741(17)230901(10)71000204
• Combination Product (y/n): N
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

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: 09/01/2023
• Device Model Number: G30474
• Device Catalogue Number: HWS-035150
• Device Lot Number: 71000204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 03/18/2021
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1