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 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510k # ¿ 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, during an unspecified procedure, the user opened the package of a filiform double pigtail ureteral stent set and found the stent was broken.A same type device was opened to complete the procedure.The issue with this device was discovered prior to making contact with the patient and it was not used.There was no impact to the patient.

Manufacturer Narrative

Description of event: as reported, during an unspecified procedure, the user opened the package of a filiform double pigtail ureteral stent set and found the stent was broken.A same type device was opened to complete the procedure.The issue with this device was discovered prior to making contact with the patient and it was not used.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, and quality control data.One filiform double pigtail ureteral stent was returned for investigation.The stent was returned in 2 segments with what appeared to be mating fractures indicating all sections of the stent were returned.The point of separation was approximately 16.5cm from the distal coil.The stent was returned with the tether attached.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, 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 the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied upon removal from the package, inspect the product to ensure no damage has occurred.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.A review of the device master record found manufacturing controls to be in place to assure device integrity prior to shipment a cause for the complaint could not be established.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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

There is no new patient or event information to report.

• 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: 12151515
• MDR Text Key: 261075985
• Report Number: 1820334-2021-01749
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002151465
• UDI-Public: (01)10827002151465(17)230623(10)13262901
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• 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: 13262901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1