MAUDE Adverse Event Report: COOK INC C-FLEX DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL

Model Number N/A

Device Problems Difficult to Remove (1528); Unraveled Material (1664)

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

Event Date 03/13/2022

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.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

It was reported that the guide wire of an c-flex double pigtail ureteral stent set, met resistance at removal and was noted to be "bent and deformed" after removal during a laparoscopic pyeloplasty to the left ureter.No adverse effects were reported to the patient, there was not any unintended section of the device remaining in the patient.Another device of the same type was used to successfully complete the procedure.

Manufacturer Narrative

Event summary: it was reported that the guide wire of an c-flex double pigtail ureteral stent set, met resistance at removal and was noted to be "bent and deformed" after removal during a laparoscopic pyeloplasty to the left ureter.No adverse effects were reported to the patient, there was not any unintended section of the device remaining in the patient.Another device of the same type was used to successfully complete the procedure.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu, and quality control (qc) procedures were conducted during the investigation.It was reported the complaint device would not be returned.A photo was provided that shows the wire guide unravelled and kinked.Another photo shows the product label which indicates it is from lot 14311401.A document-based investigation evaluation was performed.A complaint history database search showed no other related complaints associated with the complaint device lot 14311401.A search of the complaint database [device history record] for lot 14311401 found two non conformances for 'bent/kinked' wires which is similar to the reported failure mode; the identified devices were scrapped prior to lot release.Because 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.Instructions for use the set is supplied with ifu t_cfmus_rev2 which includes the following precautions ¿ manipulation of the wire guide requires appropriate imaging use caution not to over manipulate the wire guide when gaining access.¿ when a wire guide through a metal cannula/needle, use caution as damage may outer to the outer coating ¿ when exchanging or withdrawing an instrument over the wire guide, secure and maintain the wire guide in place under fluoroscopy in order to avoid unexpected wire guide displacement ¿ these wire guides are not intended for ptca used based upon the available information and results of the investigation, cook has concluded that the 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.

Event Description

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

• Brand Name: C-FLEX DOUBLE PIGTAIL URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• 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: 15855701
• MDR Text Key: 307901620
• Report Number: 1820334-2022-01768
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162104
• 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: 02/20/2023

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: N/A
• Device Catalogue Number: 036314
• Device Lot Number: 14311401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 01/23/2023
• Supplement Dates FDA Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• 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
• Patient Sex: Male