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

Catalog Number 133624-01

Device Problems Break (1069); Patient Device Interaction Problem (4001)

Patient Problem Calcium Deposits/Calcification (1758)

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Device available for evaluation: device available for evaluation: unknown.Device evaluated by mfr: device evaluated by mfg = other (code unspecified, describe in (81): device return unknown.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

It was reported that a black silicone filiform double pigtail ureteral stent was heavily encrusted.The stent was placed by another provider in (b)(6) 2021.The patient's first procedure was to remove renal calculi debris and a 7cm bladder stone.The patient then had a second procedure (eswl lithotripsy and ureteroscopy) to attempt to remove the encrustation and stent.During the second procedure, the user was able to remove more calculi debris at the distal portion of the stent and around the distal coil at the bladder.When the user attempted to remove the stent, the stent broke at the proximal end.The user used semi-rigid and flexible scopes during the procedures.The proximal end of the coil is currently straight in the ureter.The patient is scheduled for another eswl lithotripsy procedure to remove the stent and remaining encrustation on (b)(6) 2023.Additional information regarding event details, patient anatomy and outcome has been requested but is not available at this time.

Event Description

Additional information was received on 15feb2023 stating that the doctor in this complaint was mistaken and the encrusted stent/device that was removed on (b)(6) 2023 was not a cook black silicone filiform double pigtail ureteral stent.Due to the patient having the stent placed at another facility, by another provider, over 18 months prior, it is unknown what type of stent was placed.The doctor in this complaint expressed satisfaction in the results experienced with the cook black silicone filiform double pigtail ureteral stent.This complaint will be closed based upon this additional information.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.B5: additional information received 15feb2023.Corrected fields: d9, h3, h6 (annex b, c, d).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.

• Brand Name: BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT
• 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: 16383760
• MDR Text Key: 309637093
• Report Number: 1820334-2023-00142
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 133624-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 02/15/2023
• Supplement Dates FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention