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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter name and address: (b)(6).Pma/510(k) number- preamendment.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, the stent of a filiform double pigtail ureteral stent set was found separated when the package was opened.The tether was removed by the customer.The device did not make patient contact.A new device was used to complete the procedure.There was no reported impact to the patient as a result of this occurrence.

Manufacturer Narrative

Event summary: as reported, the stent of a filiform double pigtail ureteral stent set was found separated when the package was opened.The tether was removed by the customer.The device did not make patient contact.A new device was used to complete the procedure.There was no reported impact to the patient as a result of this occurrence.Investigation - evaluation: reviews of the complaint history, device history record, drawing, instructions for use, and quality control procedures were conducted during the investigation.The complaint device was lost in shipping and was not returned for investigation.Photos of the device were provided which shows the tether is separated from the stent.The stent is separated in two at approximately the middle of the stent.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.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.A review of relevant manufacturing documents was conducted.No gaps were discovered during reviews of the device manufacturing instructions or quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use provided with the device state, ¿do not force set components during placement, replacement, or removal.Carefully remove the set components if any resistance is encountered.¿ based on the available information, cook has concluded that a cause for the complaint cannot be established.It was not possible to rule oiy shipping/handling or the removal of the tether as possible contributing factors to the complaint.Cook will continue monitoring of similar complaints and has 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: 11803796
• MDR Text Key: 266480722
• Report Number: 1820334-2021-01316
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002151465
• UDI-Public: (01)10827002151465(17)231130(10)13593096
• 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: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 133626
• Device Lot Number: 13593096
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1