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

Model Number G17306

Device Problems Peeled/Delaminated (1454); Unraveled Material (1664)

Patient Problem Insufficient Information (4580)

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

As reported, a c-flex multi-length ureteral stent set was used during a ureteroscopy with stone fragmentation.Upon insertion, the coating on the guide wire in the stent set had the coating come "loose" at the tip.A second, same type device was used during the procedure and experienced the same issue (captured under patient identifier (b)(6)).There have been no adverse effects reported due to this occurrence.Additional patient/event information has been requested.

Event Description

Two complaint devices were returned to cook for investigation, however, cook is unable to determine which wire is for which complaint due to them being returned in the same package.The first wire (captured under this complaint) was returned unraveled.The second wire (captured under manufacturer report # 1820334-2023-00026) was returned unraveled and separated.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.H3: (other): device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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.

Manufacturer Narrative

Event description: as reported, a c-flex multi-length ureteral stent set was used during a ureteroscopy with stone fragmentation.Upon insertion, the coating on the guide wire in the stent set had the coating come "loose" at the tip.A second, same type device was used during the procedure and experienced the same issue (captured under mdr # 1820334-2023-00026).The two complaint devices were returned to cook for investigation; however, cook is unable to determine which wire is for which complaint due to them being returned in the same package.The first wire (captured under this complaint) was returned unraveled.The second wire (captured under manufacturer report # 1820334-2023-00026) was returned unraveled and separated.Investigation evaluation: reviews of documentation, including the complaint history, device history record (dhr), instructions for use (ifu) and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.Two wire guides were returned with only labels from original packaging to cook for investigation.However, cook is unable to determine which wire is for which complaint due to them being returned in the same package.The first wire (captured under this complaint) was returned unraveled.Approximately 15cm of the guide wire had a stretched appearance with the inner core wire visible.The second wire (captured under manufacturer report # 1820334-2023-00026) was returned unraveled and separated.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the complaint lot records no relevant non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Cook concluded that no nonconforming product from this lot exists in house or in the field.Cook also reviewed product labeling.The current instructions for use state the following: precautions: manipulation of the wire guide requires appropriate imaging use caution not to overmanipulate the wire guide when gaining access.When using a wire guide through a metal cannula/needle, use caution as damage may outer to the outer coating.It is not known if imaging or a metal cannula/needle were used when placing the wire guide.Cook has concluded a cause of the complaint cannot be established.Due to lack of information about the procedure it is not possible to rule out procedural factors.The appropriate personnel have been notified and we will continue to monitor for similar complaints.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 MULTI-LENGTH 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 ; 8128294891
• MDR Report Key: 16154536
• MDR Text Key: 308028882
• Report Number: 1820334-2023-00025
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002173064
• UDI-Public: (01)00827002173064(17)250720(10)14850632
• Combination Product (y/n): N
• PMA/PMN Number: K162104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2023

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: G17306
• Device Catalogue Number: 036300-T-8-20
• Device Lot Number: 14850632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 01/13/2023; 02/01/2023
• Supplement Dates FDA Received: 01/30/2023; 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• 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