MAUDE Adverse Event Report: COOK INC FILIFORM DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL

Catalog Number 133626

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2020

Event Type  malfunction  

Manufacturer Narrative

Name and address: (b)(6).Pma/510k #: pre-amendment.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, prior to a ureteroscopic holmium laser lithotripsy using a filiform pigtail ureteral stent, the physician opened the package and the stent was discovered broken.An image provided appears to show a complete separation across the body of the stent.The user changed to another new device of the same type to successfully complete the procedure.No adverse effects have been reported due to the alleged malfunction.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, prior to a ureteroscopic holmium laser lithotripsy using a filiform pigtail ureteral stent, the physician opened the package and the stent was discovered broken.An image provided appears to show a complete separation across the body of the stent.The user changed to another new device of the same type to successfully complete the procedure.No adverse effects have been reported due to the alleged malfunction.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, and quality control procedures and a visual inspection of the device were conducted during the investigation.One filiform double pigtail ureteral stent set was returned for investigation in a prior to use condition.The positioner was not returned.The stent was returned separated into two segments.The proximal segment measured 7.8cm with the coil still attached.The tether remained attached and was tangled around the stent body.The tether was severed 15.5cm from the knot.The distal segment measured 18.3cm with the distal coil still attached.The points of separation had mating fractures and occurred at a sideport, indicating no missing pieces.Magnification of the severed ends showed both ends have a jagged edge.A document-based investigation evaluation was also performed.No related non-conformances were recorded, and no other lot-related complaints were received.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the device quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions which caution, ¿improper handling can seriously weaken the stent.Acute bending or overstressing during placement may result in subsequent separation of the stent at the point of stress after a prolonged indwelling period.¿ based on the available information, cook has concluded that the cause of the stent separation could not be established.Cook will continue monitoring of similar complaints and have notified the appropriate personnel of this event.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: FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10835464
• MDR Text Key: 216325732
• Report Number: 1820334-2020-02086
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002151465
• UDI-Public: (01)10827002151465(17)230623(10)13262906
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

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 Expiration Date: 06/23/2023
• Device Catalogue Number: 133626
• Device Lot Number: 13262906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1