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

Catalog Number NTSED-024115-UDH

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation: materials buyer.Pma/510(k) #- 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, prior to use in a ureteroscopy, the basket of an ncircle delta wire tipless stone extractor would not close.The device was tested before and after removal from the holder, and would not close with either test.A kink was noted in the wire at the handle of the device.Another device of the same type was used to successfully complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Event summary: cook was informed of an incident involving a ncircle delta wire tipless stone extractor.It was reported that the basket would not close before removing it from the holder that it comes in.It still would not work after removal from the package.There was a kink noted in the wire at the handle.The procedure was successfully completed with another device of the same type.The patient reportedly experienced no harm as a result of the issue.Investigation ¿ evaluation: a visual inspection and functional testing of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, and quality control data.The device was returned with the handle and the basket formation in the open position.The mlla (male luer lock adapter) was loose, and the collet knob was tight and secure.The polyethylene terephthalate tubing [pett] measured 3.2 cm in length.Approximately 2mm of the basket formation protrudes from the basket sheath when in a closed position.The support sheath was severely bent starting at the 1cm from the nose of the mlla.The basket sheath was frayed near the distal end of the support sheath.There were kinks in the basket sheath located at 41.5cm and 92cm from the distal tip.Function test determines the handle does open the basket formation, but does not close completely.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precaution: enclose the device in the sheath before removing from the tray/holder.Precaution: do not use excessive force to manipulate this device.Damage to the device may occur.The provided information stated the issue occurred before removing the device from the tray.Though it is possible the device was damaged when loading the device into the device tray or during shipping, there is not enough evidence to make a conclusion as to the cause of the damage.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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.

Event Description

No new patient or event information since the last report was submitted.

• Brand Name: NCIRCLE DELTA WIRE 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: 11238545
• MDR Text Key: 234939616
• Report Number: 1820334-2021-00175
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002191102
• UDI-Public: (01)10827002191102(17)230918(10)13438473
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2023
• Device Catalogue Number: NTSED-024115-UDH
• Device Lot Number: 13438473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1