MAUDE Adverse Event Report: COOK INC NGAGE NITINOL STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL

Catalog Number NGE-022115-MB

Device Problem Difficult to Open or Close (2921)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Phone: (b)(6).Pma/510k #: exempt.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 flexible ureteroscopy in the kidney using a ngage nitinol stone extractor, the basket failed to close.The wires of the device were open when taken out of the package, but when the user attempted to close the basket to introduce into the ureteroscope, it failed to do so.The device was tested prior to use.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.No adverse effects were reported due to the alleged malfunction.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary as reported, during a flexible ureteroscopy in the kidney using a ngage nitinol stone extractor, the basket failed to close.The wires of the device were open when taken out of the package, but when the user attempted to close the basket to introduce into the ureteroscope, it failed to do so.The device was tested prior to use.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.No adverse effects were reported due to the alleged malfunction.Investigation - evaluation reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection and functional test of the device were conducted during the investigation.One ngage nitinol stone extractor was returned for investigation with the handle and basket formation in the open position.The male luer lock adapter was tight, and the collet knob was tight and secure.The polyethylene terephthalate tubing measures 3.5cm in length.A function test determined the handle actuates the basket formation, but the basket formation did not close all the way.There was a kink in the basket sheath approximately 50.2 cm from distal tip.The support sheath was straight.The handle was disassembled.The cannulated handle was straight and could manually actuate the basket formation with resistance.The handle was reset and reassembled, after which the handle could actuate the basket formation.Coiling was inside the basket sheath when in the closed position.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the manufacturing instructions or quality control procedures.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, ¿excessive force could damage device.¿ the returned device was found to have a basket that would not fully close due to sheath damage.Based on available evidence, cook has that a cause could not be established for this event.It is possible the sheath was inadvertently damaged during unpacking or subsequent handling, but no information related to handling was known, so the cause could not be conclusively determined.Cook will continue monitoring of similar complaints and have 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.

Event Description

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

• Brand Name: NGAGE NITINOL STONE EXTRACTOR
• Type of Device: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11333192
• MDR Text Key: 241204457
• Report Number: 1820334-2021-00340
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482965
• UDI-Public: (01)10827002482965(17)230723(10)13323853
• 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: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2023
• Device Catalogue Number: NGE-022115-MB
• Device Lot Number: 13323853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1