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 06/30/2021

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: 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, a filiform double pigtail ureteral stent was found separated during removal.The device was deployed (b)(6) 2020 and was difficult to visualize on x-ray taken (b)(6) 2021.During subsequent removal, the device was observed in three pieces under fluoroscopy.The stent was successfully removed from the patient.No adverse effects to the patient were reported as a result of this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b1, b2, b5, h1, h6 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

Additional information was received 15jul2021.The separated device segments were removed from the patient through a cystoscope using stent removal forceps.

Manufacturer Narrative

Event description: as reported, a filiform double pigtail ureteral stent was found separated during removal.The device was deployed (b)(6) 2020 and was difficult to visualize on x-ray taken (b)(6) 2021.During subsequent removal, the device was observed in three pieces under fluoroscopy.The separated device segments were removed from the patient through a cystoscope using stent removal forceps.No additional patient consequences were reported.Investigation ¿ evaluation: a document based investigation was performed including a review of, drawing, manufacturing instructions, 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 (dhr) and complaint history records could not be completed due to lack of lot information from the user facility.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A device master record review was performed, including drawings, manufacturing instructions, and quality control procedures.Cook has concluded that sufficient inspection activities are in place to assure functionality and device integrity prior to shipping.The instructions for use (ifu), provides the following information to the user.¿the stent must not remain indwelling more than twelve months.If the patient¿s status permits, the stent may be replaced with a new stent.¿ the stent was reported to have been placed (b)(6) 2020, the visibility issue was reported during an x-ray on (b)(6) 2021.The stent was reportedly removed on (b)(6) 2021, which would be approximately 41 days over the precaution listed in the ifu.¿improper handling can seriously weaken the stent.Acute bending or overstressing during placement may result in subsequent separation of the stent at the point of stress after a prolonged indwelling period.¿ it is unknown how the stent was inspected and prepared prior to placement.It is possible that inadvertent bending and manipulation of the device prior to placement contributed to weakening in the stent material.It is possible that patient anatomy and manipulation during the placement procedure contributed to the device separation.¿periodic evaluation via cystoscopic, radiographic, or ultrasonic means is suggested.¿ it is unknown if any form of period evaluation occurred during the time the device was indwelling.Cook has concluded based on the information provided for the most probable cause of this event is related to the indwelling time of the device.Based on the information, product handling, medical procedure, inadvertent user error, or device failure should be considered as other possible causes of this event.The risk assessment 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: 12174132
• MDR Text Key: 262281696
• Report Number: 1820334-2021-01816
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 133626
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention