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

Model Number G48294

Device Problems Difficult to Open or Close (2921); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: perioperative inventory manager.Pma/510(k) #: exempt.(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 when the doctor was performing the ureteroscopy, the first ngage basket would not completely open and shut properly.He tried using the device and while using it, the device started ¿shredding¿ down the plastic sheath.Another ngage was then opened and this basket would also not open and close properly.The case was completed as normal.No extra measures needed to be taken.No piece of the device was left in the patient.Additional patient and event information has been requested.At the time of this report, no additional information has been provided.This report captures the first basket malfunction reported to occur during the procedure.It is related to mfr.Report # 1820334-2019-00660 which addresses the second basket issue.

Manufacturer Narrative

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, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.One device was returned for investigation.The returned packaging confirms complaint device lot number 9486119.Inspection of the returned open device noted the device was returned with the handle in the open position and the basket formation was partially closed.Visual examination noted a kink in the basket sheath 7 cm from distal tip.With the basket formation in closed position, a gap is visible in the wires.Functional testing found the handle actuates the basket formation to the open position, but it does not close completely.A review of the device history record found no non-conformances related to the reported failure mode.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: important: enclose device in sheath before removing from tray/holder.Important: excessive force could damage device.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 returned device was found to have a basket that would open and close, but not close fully.A gap was visible between the basket wires when the device was in the closed position.A kink was observed 7 cm from the distal end of the sheath.The kink was possibly affecting device function, preventing the basket from closing fully.No evidence of the alleged "shredding" of the plastic sheath was observed.The cause for the kinked sheath could not be conclusively determined.The sheath may have become damaged during packaging, handling of the device, during use, or perhaps during return shipping.Per the quality engineering risk assessment, no further action is warranted.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.

Event Description

Patient demographics and pre-existing conditions were provided on19mar2019.A laser was utilized during the procedure.

• 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: 8436831
• MDR Text Key: 139342387
• Report Number: 1820334-2019-00659
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482944
• UDI-Public: (01)00827002482944(17)220130(10)9486119
• 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: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2022
• Device Model Number: G48294
• Device Catalogue Number: NGE-017115
• Device Lot Number: 9486119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Date Manufacturer Received: 03/19/2019
• Patient Sequence Number: 1
• Treatment: LASER
• Patient Age: 72 YR
• Patient Weight: 108