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

Catalog Number 133628

Device Problem Unraveled Material (1664)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/16/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 urinary tract procedure, a wire guide of a filiform double pigtail ureteral stent set unraveled.The user advanced the stent over the wire guide with noted difficulty.They then attempted to pull back on the wire guide when it began to unravel.The stent was eventually placed.No portion of the device was left in the patient, however the patient did report having urinated out some "small metallic dust" the next day.

Manufacturer Narrative

Event summary: as reported, during an unspecified urinary tract procedure, a wire guide of a filiform double pigtail ureteral stent set unraveled.The user advanced the stent over the wire guide with noted difficulty.They then attempted to pull back on the wire guide when it began to unravel.The stent was eventually placed.No portion of the device was left in the patient, however the patient did report having urinated out some "small metallic dust" the next day.Investigation - evaluation: a document-based investigation was performed including a review of complaint history, device history record, manufacturing instructions, drawing, quality control data, the instructions for use (ifu), and interviews with personnel.A device failure analysis was not able to be conducted as the device was not returned by the customer.Images provided by the customer depicted the wire unraveling in detail.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.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: manipulation of the wire guide requires appropriate imaging control.Use caution not to force or overmanipulate the wire guide when gaining access.When using a wire guide through a metal cannula/needle, use caution as damage may occur to the outer coating.Do not force set components during placement, replacement, or removal.Carefully remove the set components if any resistance is encountered.How supplied.Sterile if package is unopened or undamaged.Do not use the product 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 package, inspect the product to ensure no damage has occurred.Based on the available information, cook has concluded that a cause of this event could not be established.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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

No new patient or event information since the last report was submitted.

• 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 ; 8128294891
• MDR Report Key: 12712738
• MDR Text Key: 278832660
• Report Number: 1820334-2021-02400
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002151472
• UDI-Public: (01)10827002151472(17)240607(10)14010573
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

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 Catalogue Number: 133628
• Device Lot Number: 14010573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 04/11/2022
• Supplement Dates FDA Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2021
• 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