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 09/02/2021

Event Type  malfunction  

Manufacturer Narrative

Name and address: (b)(6); phone: (b)(6).Pma/510(k) #- 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, a filiform double pigtail ureteral stent was found broken at the pigtail when opening the device packaging.The device did not make patient contact.Another device was used instead to complete the procedure.There was no impact to the patient as a result of this occurrence.

Event Description

No new patient or event information to report since the previous medwatch report was submitted.

Manufacturer Narrative

Summary of event: as reported, a filiform double pigtail ureteral stent was found broken at the pigtail when opening the device packaging.The device did not make patient contact.Another device was used instead to complete the procedure.There was no impact to the patient as a result of this occurrence.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device and personnel interviews were also conducted.The complainant returned one black silicone double pigtail stent to cook for investigation in open packaging.The stent was returned in 2 pieces, with one pigtail separated at the end of the curve.The tether was not returned.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.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the product labeling.The instructions for use (ifu) provides the following to the user related to the reported failure mode: precautions the tether should be removed if the stent is to remain indwelling longer than 14 days.Instructions for use tether options removed prior to stent placement: remove tether by holding the knot, cutting one strand, and while holding the knot, gently pull on the tether.How supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened and undamaged.Do not use if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from the package, inspect the product to ensure no damage has occurred.Based on the available information, a root cause for this incident was unable to be determined.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.

• 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
• 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: 12474619
• MDR Text Key: 271488568
• Report Number: 1820334-2021-02159
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002151465
• UDI-Public: (01)10827002151465(17)231110(10)13544792
• Combination Product (y/n): N
• 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: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2023
• Device Catalogue Number: 133626
• Device Lot Number: 13544792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2020
• 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