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

Catalog Number NTSE-022115-UDH

Device Problems Detachment Of Device Component (1104); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2018

Event Type  Injury  

Manufacturer Narrative

(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 a mini percutaneous nephrolithotomy (pcnl) procedure while using the ncircle tipless stone extractor basket, the tip of the basket ripped apart with the tip detaching inside the patient¿s kidney.To remove the tip of the basket out of the kidney they used the mini pcnl nephroscope and small reusable forceps.This worked without problems.The procedure was completed using a different basket.No unintended section of the device remained inside the patient¿s body.No additional procedures were required.There were no adverse consequences or effects to the patient due to this occurrence.

Manufacturer Narrative

A visual inspection and functional testing of the returned device was conducted.In addition, a review of complaint history, the device history record, drawings, instructions for use, manufacturing instructions, quality control data, and specifications was performed.One device was returned for investigation.The device was returned with the handle in the closed position.The basket formation was in the closed position.The collet knob is tight and secure.The male luer lock adaptor (mlla) is tight.The polyethylene terephthalate tubing (pett) measures 2.5 cm in length.A functional test determined the handle does not actuate the basket formation.A visual examination noted kinks in the basket sheath at 36 cm and 39 cm from the distal tip of the basket sheath.The handle was disassembled; finding the basket formation completely separated.There are wires protruding at the distal end of the cannula; one extending 5 mm and the other extends 1 cm.The basket formation has the appearance of being pulled, stretched, and possibly ¿hooked¿ on something.The knot has come loose.The support sheath and the basket sheath are still adhered.The coil assembly will manually actuate.It appears the device has met resistance beyond its intended design.The device history record was reviewed and noted there were no non-conformances related to the reported failure.A review of complaint history revealed this complaint is the only one associated with lot number 8481728.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The ntse-022115-udh is used for stone manipulation and removal in the urinary tract.The nitinol wire allows the basket to retain its shape following extreme torsion.There is no information regarding the procedure or any procedural difficulties that may have contributed to the basket breaking off.Per the instructions for use (ifu), ¿do not use excessive force to manipulate this device.Damage to the device may occur.¿ it is not known if the device was tested prior to use.There is no information regarding preparation or handling of the device.As provided in the ifu, ¿upon removal from the package, inspect the product to ensure no damage has occurred.¿ no information was provided regarding other devices used in this procedure or the patient anatomy that may have contributed to the basket separation.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.There is no indication from the document review that there is nonconforming product in the field.Devices are inspected for damage and functionality prior to packaging.The observed damage likely occurred during use of the device.The ifu contains multiple cautions about manipulating the device to prevent damage.There is no information related to device manipulation, therefore it could not be concluded that the device was damaged by the user.Measures have been initiated to address the reported failure mode.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database 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.Blank fields on this form indicate the information is unknown, unchanged, or unavailable.

• Brand Name: NCIRCLE TIPLESS 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: 7348635
• MDR Text Key: 102739961
• Report Number: 1820334-2018-00595
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002187788
• UDI-Public: (01)00827002187788(17)210102(10)8481728
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-022115-UDH
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention