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

Catalog Number NGE-017115-MB

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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 during a stone retrieval procedure, the ngage nitinol stone extractor basket failed to deploy once in the renal calyx. A new basket was used to complete the procedure. No unintended section of the extractor remained inside the patient¿s body. No additional procedures were required due to this occurrence. There were no adverse effects to the patient.

Event Description

Additional information received on 11sep2018. The basket was tested prior to use on the patient. When tested it opened and closed. When inserted into patient it would not open.

Manufacturer Narrative

Evaluation conclusion codes: cause not established (4315). 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, the device history record, drawings, instructions for use, manufacturing instructions, and quality control data. One device was returned for investigation. The device was returned with the handle and the basket formation in the closed position. The collet knob is tight and secure. The male luer lock adapter (mlla) is finger tight. The polyethylene terephthalate tubing (pett) measures 3. 7 cm in length. A visual examination noted the support sheath is bowed at the mlla. The basket sheath was found to have a kink approximately 72. 5 cm from the distal tip. A functional test determined the handle actuates the basket formation. When pushing on the slide button to the end, in the closed position, the basket formation gaps. A review of the device history record found there were no non-conformances associated with the complaint device lot number 8661849. A review of complaint history records revealed no other complaint has been reported for lot number 8661849. According to the instructions for use (ifu): caution: this device is conductive. Avoid contact with any electrified instrument. Caution: sterile if the package is unopened or undamaged. Do not use if package is broken. Important: enclose device in sheath before removing from tray/holder. Important: excessive force could damage device. 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. The complaint device was found to have a basket that would not close fully due to sheath damage. The sheath was found to be kinked and the support sheath was bowed. The observed damage prevented the basket subassembly from moving freely within the sheath when the handle was functioned. Devices are inspected for damage and functionality prior to packaging. The observed damage likely occurred during handling/use of the device. The ifu contains cautions about manipulating the device to prevent damage. Since no information related to product handling is available, the definitive cause could not be established. 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.

• 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: 7851633
• Report Number: 1820334-2018-02619
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482951
• UDI-Public: (01)00827002482951(17)210313(10)8661849
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/13/2021
• Device Catalogue Number: NGE-017115-MB
• Device Lot Number: 8661849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/11/2018

Is This a Reprocessed and Reused Single-Use Device?