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

Catalog Number 133630

Device Problem Material Separation (1562)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2021

Event Type  Injury  

Manufacturer Narrative

Occupation: manager.Pma/510k #: pre-amendment.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 a ureterscopy with laser lithrotripsy, while attempting to extract a filiform double pigtail ureteral stent, the pigtail of the stent separated from the stent.The stent was placed in (b)(6) 2020 for kidney drainage.The patient has a tortuous ureter.The separated section of the stent was hanging off the ureteral orifice, and the physician was able to grasp the separated section of the stent using a grasping forceps.The device was removed from the patient successfully, and no segment of the device remained inside the patient.No additional patient consequences were reported.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Event summary as reported, during a ureterscopy with laser lithrotripsy, while attempting to extract a filiform double pigtail ureteral stent, the pigtail of the stent separated from the stent.The stent was placed in (b)(6) 2020 for kidney drainage.The patient has a tortuous ureter.The separated section of the stent was hanging off the ureteral orifice, and the physician was able to grasp the separated section of the stent using a grasping forceps.The device was removed from the patient successfully, and no segment of the device remained inside the patient.No additional patient consequences were reported.Investigation - evaluation reviews of the complaint history, quality control procedures, specifications, drawing, and a visual inspection were conducted during the investigation.One filiform double pigtail ureteral stent set was returned for investigation.The device stent was received in a biohazard bag, no label or packaging.The device was returned in two segments, the proximal segment measured 29 cm and the distal segment measured 1.5 cm.Severed encrustation was observed on the distal segment, and slight encrustation was noted on the proximal segment.The points of separation appeared to match.A document-based investigation evaluation was performed.Product lot information was not provided by the user.Reviews of the device history record and complaint history were unable to be conducted.Because adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related evidence is available, it was concluded that there is no evidence that nonconforming product exists in house or in field.Reviews of the quality control, specifications, and drawing were conducted, and no gaps were discovered.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use provided with the device state the following precautions: ¿ 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.Individual variations of interaction between stents and the urinary system are unpredictable.Periodic evaluation via cystoscopic, radiographic, or ultrasonic means is suggested.The stent must be replaced if encrustation hampers drainage.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.¿ based on the available information and clinical assessment of the event, the most probable contributing factors to this event are patient anatomy, device handling, or user technique.Cook has concluded that a definitive cause for this event could not be established.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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: 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: 11274093
• MDR Text Key: 230110360
• Report Number: 1820334-2021-00246
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

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: 133630
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 06/11/2021
• Supplement Dates FDA Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR