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

Catalog Number 133624

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Pma/510k #: pre-amendment.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported, during removal of a filiform double pigtail ureteral stent with a stent grasper, the stent snapped off 1-2cm from the pigtail end inside the bladder.They were able to grab the stent and remove from the patients body.No part of the stent remained inside the patient.No adverse events have been reported as a result of the alleged malfunction.

Event Description

Informed on (b)(6) 2018, that no additional information will be made available.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: investigation evaluation: the complaint device was not returned for an evaluation and no photographs were provided.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of the instructions for use and quality control data.A review of the device history record could not be performed as the lot number of the device was not provided.A review of complaint history could not be performed on the complaint device lot because the lot number was not provided.As provided in the instructions for use (ifu): -do not force set components during placement, replacement, or removal.Carefully remove the set components if any resistance is encountered.-the stent must not remain indwelling more than twelve months.If the patient's status permits, the stent maybe replaced with a new stent.-the included stent is not intended as a permanent indwelling device.-a pregnant patient must be more closely monitored for possible stent encrustation due to calcium supplements.-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.Angulation of the wire guide or stent should be avoided.Use of a 0-degree scope lens is recommended.Scopes larger than 21.0 french are suggested.A review of manufacturing and quality control documents identified that there are controls in place to ensure the tensile strength of the device.The cause of the reported failure mode could not be established.Measures have been initiated to address this issue.Monitoring will continue to be performed for similar complaints.The appropriate cook personnel have been notified of this event.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: 7995370
• MDR Text Key: 125298206
• Report Number: 1820334-2018-03128
• 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
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 133624
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WIRE GUIDE, CYSTOSCOPE, STENT GRASPER