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

Model Number G30474

Device Problems Peeled/Delaminated (1454); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2022

Event Type  malfunction  

Event Description

As reported, during a soft ureteroscopic surgery, resistance was felt when removing a hiwire nitinol hydrophilic wire guide from its protective tubing.The wire guide was forcefully pulled out of its protective tubing and a section of the wire guide coating came off, exposing the inner core.A new device was used to complete the procedure successfully.The complaint device did not make contact with the patient.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.

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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 received (b)(6) 2023.The procedure involved placement of an unspecified double pigtail stent.

Manufacturer Narrative

Correction: annex a.Summary of event: as reported, during a soft ureteroscopic surgery with placement of an unspecified double pigtail stent, resistance was felt when removing a hiwire nitinol hydrophilic wire guide from its protective tubing.The wire guide was forcefully pulled out of its protective tubing and a section of the wire guide coating came off, exposing the inner core.A new device was used to complete the procedure successfully.The complaint device did not make contact with the patient.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 (ifu), and quality control procedures were conducted during the investigation.A visual inspection and functional test of the returned device was also conducted.The complaint device was returned to cook for investigation.Approximately 7 millimeters of wire was protruding from the end of the wire coating.The device is assembled by a supplier to cook who also carried out an investigation.The supplier noted a ductile/tensile overload fracture of the polymer jacket with material removal exposing the distal.70 centimeters of the metallic core wire.A review of the device history record for by cook and the supplier found no related anomalies.A database search carried out by cook found no other complaints have been reported for the complaint device lot at the time of this investigation.A review of manufacturing procedures carried out by the supplier found controls to be in place to assure device integrity prior to shipment.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: "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 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 information provided upon review of complaint file, device history record, complaint history and supplier investigation indicate the complaint device was manufactured to specification.Based on the available information and results of the investigation, cook has concluded that a cause for the complaint could not be established.The appropriate personnel have been notified and cook will continue to monitor for similar events.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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 16000533
• MDR Text Key: 308452398
• Report Number: 1820334-2022-01865
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

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 Model Number: G30474
• Device Catalogue Number: HWS-035150
• Device Lot Number: 71002857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 01/20/2023
• Supplement Dates FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male