MAUDE Adverse Event Report: COOK INC SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL

Model Number G15608

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: materials management.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.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

It was initially reported the guidewire (which is.018 / 60 cm) that is included in the sof-flex pediatric double pigtail ureteral stent set shredded on the way out of the scope.It is unknown if portions detached or specifics as to the nature of the shredding.Additional information was received on 21mar2019.Nothing had to be retrieved from the patient¿s body.No unintended section of the device remained inside the patient¿s body.The type of scope used could not be recalled.The procedure was performed transurethrally and the patient was unaffected by this issue.Additional information was received on 22mar2019.This was an ureteral stent placement procedure to allow drainage from the kidney to the bladder.There were no additional procedures required and there were adverse effects on the patient due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation.A visual inspection and dimensional verification of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, drawings, instructions for use, manufacturing instructions, quality control data, and specifications.The complainant returned one wire guide for investigation.Visual examination noted the distal end of the wire guide was damaged.The outer coiling appeared to have separated off.Only the inner mandril was left at the distal end.Approximately 1.3 cm protruded from the end of the remaining coil.The solder connection remained intact and undamaged.It was located proximal to the point of failure.Dimensional analysis confirmed that the device was manufactured within the correct specifications and tolerances.A review of the device history records for the wire guide subassembly lot revealed there are no non-conformances.A review of complaint history shows no other complaints are associated with the complaint device lot number.A review of the instructions for use (ifu) found the following information related to the reported failure mode: precautions manipulation of the wire guide requires appropriate imaging control.Use caution not to force or over manipulate the wire guide when gaining access.When using a wire guide through a metal cannula/needle, use caution as damage may occur to the outer coating.When exchanging or withdrawing an instrument over the wire guide, secure and maintain the wire guide in place under fluoroscopy in order to avoid unexpected wire guide displacement.These wire guides are not intended for ptca use.Do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.Instructions for use wire guide preparation 3.Remove wire guide from holder.4.If using a movable core wire guide, adjust mandril position by advancing or withdrawing the mandril within the wire guide to achieve the required degree of flexibility.How supplied upon removal from the package, inspect the product to ensure no damage has occurred.Inspection of the returned device confirmed that the distal end of the wire guide had been sheared off.The customer stated that no portion remained within the patient.The investigation also showed no evidence that the device was not manufactured to specification.Information regarding the scope used during the procedure was not available.It is possible that the wire guide was used or removed through an incompatible component, causing it to shear upon removal.If the wire experienced excessive forces or became caught during the procedure, it could have caused the separation.It is also possible that unknown complications with the patient anatomy could have caused the wire guide to become damaged, and separate upon removal.The complaint is confirmed based on investigation of the returned device.A definitive cause for the failure mode could not be determined.Per the quality engineering risk assessment, no further action is warranted.The appropriate internal 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 event information to report.

• Brand Name: SOF-FLEX PEDIATRIC 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: 8471143
• MDR Text Key: 141488711
• Report Number: 1820334-2019-00669
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002156081
• UDI-Public: (01)00827002156081(17)201115(10)8376156
• 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: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2020
• Device Model Number: G15608
• Device Catalogue Number: 039312
• Device Lot Number: 8376156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/01/2019
• Supplement Dates Manufacturer Received: 05/10/2019
• Supplement Dates FDA Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1