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

Catalog Number HWS-038150

Device Problems Break (1069); Device Damaged by Another Device (2915)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/30/2022

Event Type  Injury  

Event Description

As reported, during a ureteroscopic lithotripsy with stone extraction, a hiwire nitinol hydrophilic wire guide separated after being cut by a laser.The separated device segment was discovered on imaging during the procedure and retrieved from the patient after reinsertion of the scope.The patient did not have tortuous, calcified, or scarred anatomy.No section of the device remains inside the patient¿s body.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Initial reporter occupation: urology coordinator.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Event summary as reported, during a ureteroscopic lithotripsy with stone extraction, a hiwire nitinol hydrophilic wire guide separated after being cut by a laser.The separated device segment was discovered on imaging during the procedure and retrieved from the patient after reinsertion of the scope.The patient did not have tortuous, calcified, or scarred anatomy.No section of the device remains inside the patient¿s body.The patient did not experience any adverse effects due to this occurrence.Investigation - evaluation reviews of the instructions for use and quality control procedures were conducted during the investigation.The device was not available for a physical evaluation.Cook could not complete a review of the device history record (dhr) or search for other complaints from the product lot due to lack of lot information from the user facility.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.Sufficient inspection activities are in place.A review of manufacturing documents conducted by the device supplier indicates 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 device is provided with instructions for use which caution, ¿manipulation of wire guide requires appropriate imaging control.¿ based on the available information, cook has concluded that the cause of the complaint is likely related to inadvertent user error, as the complaint report description indicates that a laser cut through the complaint device.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a review of risk documentation, 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
• 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: 15077855
• MDR Text Key: 296338018
• Report Number: 1820334-2022-01253
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HWS-038150
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 09/15/2022
• Supplement Dates FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention