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

Catalog Number 133626

Device Problems Material Separation (1562); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Urinary Tract Infection (2120); No Consequences Or Impact To Patient (2199)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).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, following the removal of a black silicone filiform double pigtail ureteral stent that had been indwelling for three months, the stent separated into "tiny small pieces" after it was laid onto a table.The stent was not noted to be encrusted.No part of the stent separated within the patient.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Additional event details have been requested.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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.

Event Description

Additional information that was received (b)(6) 2021, but inadvertently not reported on our previous follow up report: the stent did not separate into "tiny small pieces" after it was laid onto a table as reported in our initial mdr.It was reported, after removing the stent in one piece, the stent looked "tender." the user then tested the device and discovered it could easily be pulled into numerous smaller pieces.The patient had no symptoms of infection following the procedure, but there were enterococci in the urine culture.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.G4: pma/510k # ¿ pre-amendment.H2 follow up type: in the previous follow up mdr, we reported correction and device evaluation.We should have reported correction and additional information.B1, h1: no product malfunction occurred which would be likely to cause or contribute to a death or serious injury if the malfunction should recur.The device did not separate into "tiny pieces" after it was laid onto a table as initially reported.The user facility tested the device after removal from the patient because it looked "tender" and found that the device could easily be pulled into numerous smaller pieces.The event does meet the criteria for a serious injury, as a cook filiform double pigtail ureteral stent may have caused or contributed to an illness which likely necessitated medical intervention to preclude permanent impairment of a body function.It was reported that the patient had no symptoms of infection, but there were enterococci in the urine culture after the stent was removed.It is unknown what was done to treat the enterococci, but it is very likely the patient received some type of antibiotic therapy.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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.

Manufacturer Narrative

Event description: as reported, a patient had a positive urine culture for enterococcus after a filiform double pigtail ureteral stent set was used.The patient had no symptoms of infection.It is unknown what was done to treat the enterococci, but it is very likely the patient received some type of antibiotic therapy.No additional patient consequences were reported.Investigation ¿ evaluation a document based investigation was performed including a review of complaint history, device history record (dhr), drawing, the instructions for use (ifu), and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest this device was manufactured out of specification.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints of a same/similar failure mode associated with the complaint device lot.A device master record review was performed, including review of quality control procedures.Cook has concluded that sufficient controls are in place to assure device sterility prior to shipping.There is no evidence that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house are nonconforming.The instructions for use (ifu), provides the following information to the user.How supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.The presence of an indwelling urinary catheter is a known risk factor for the development of a urinary tract infection (uti).These infections are classified as cautis, or catheter-associated urinary tract infections.It is possible that user handling and technique during placement of the cook stent may have contributed to the infection; however, the infection was not reported until the stent was removed, so this is not likely.It is reasonable to conclude that user or procedural issues/technique during placement/maintenance of the stent contributed to the infection.The specific medical conditions and patient diagnoses are unknown; therefore, patient condition cannot be ruled out as a contributing factor for the uti.The risk analysis for this failure mode was reviewed, and it was determined that no actions are required.The appropriate personnel have been notified, and we will continue to monitor 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: 11026768
• MDR Text Key: 223615137
• Report Number: 1820334-2020-02322
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2022
• Device Catalogue Number: 133626
• Device Lot Number: 9915870
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention