MAUDE Adverse Event Report: COOK INC FIXED CORE WIRE GUIDE

Catalog Number 635413-10

Device Problem Unraveled Material (1664)

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

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

Catalog number: device is not marketed in the united states.There are similar devices marketed in the united states, for example catalog number 635413.Information for 635413: common device name (d2a): ocy endoscopic guidewire, gastroenterology-urology, product code(d2b): ocy, pma/510(k) # (g4): k082536.Initial reporter name and address: postal code: (b)(6).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As reported, during a ureteroscopy (urs), the fixed core wire guide unraveled as it was withdrawn from the ureteral access sheath.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to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.At the time of this report, no further information has been provided.

Event Description

Additional information was received on 13oct2021: the wire guide was not withdrawn through a needle.There was no kinking or damage to the wire guide noted prior to the procedure.There was no difficulty in advancing the wire guide.They removed the sheath and used a second wire guide to complete the procedure.

Manufacturer Narrative

The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, during a ureteroscopy (urs), the fixed core wire guide unraveled as it was withdrawn from the ureteral access sheath.The wire guide was not withdrawn through a needle.There was no kinking or damage to the wire guide noted prior to the procedure.There was no difficulty in advancing the wire guide.They removed the sheath and used a second wire guide to complete the procedure.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.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, documentation, quality control data, and specifications.One used and damaged wire guide was returned.The mandril was protruding from the wire guide at approximately 139cm.The wire was unraveled.Both weld balls were present.A review of the device history record found no non-conformances related to the reported failure mode.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 lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.This complaint device is not packaged with instructions for use.Cook concluded the cause of the event to be component failure.Per the quality engineering risk assessment, no further action is warranted.Cook 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

There is no new patient or event information to report.

• Brand Name: FIXED CORE WIRE GUIDE
• 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: 12469515
• MDR Text Key: 272487966
• Report Number: 1820334-2021-02157
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002341340
• UDI-Public: (01)00827002341340(17)240225(10)13781567
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2024
• Device Catalogue Number: 635413-10
• Device Lot Number: 13781567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2021
• 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