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

Catalog Number NGE-022115-MB

Device Problems Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The customer reported during a case, two ngage nitinol stone extractors were used.As reported, the basket formation would not close on either of these devices.No additional procedures were required as a result of the two basket formations not closing.No section of the device was left inside the patient's body.As reported, there were no adverse effects to the patient due to these issues.Additional patient and event detail has been requested.

Manufacturer Narrative

Investigation: a review of the complaint history, device history record, specifications, quality control and a visual inspection of the returned devices was conducted.Two ngage nitinol stone extractors were returned for evaluation.Device a was returned with the handle in the closed position.The basket formation was in the closed position.The collet knob was tight and secure.The male luer lock adaptor (mlla) was tight.The polyethylene terephthalate tubing (pett) measured 3.5 cm in length.The handle actuated the basket formation, but did not close completely.A visual examination noted a kink in the basket sheath 106 cm from the distal tip.There was also a kink at the base of the support sheath.The handle was disassembled.The basket formation could be manually actuated to the open and closed positions.The handle was reset and reassembled; function test noted the handle actuated the basket formation to the open and completely closed positions now.Device b was returned with the handle in the closed position and the basket formation was partially closed.The collet knob was tight and secure.The male luer lock adaptor (mlla) is tight.The polyethylene terephthalate tubing (pett) measured 3.5 cm in length.A visual examination noted the support sheath was bowed in appearance.A kink was noted in the basket sheath 106 cm from the distal tip.A functional test determined the handle did not actuate the basket formation.The handle was disassembled and the basket formation will not expand.Under magnification, a wire was noted to be broken 2 mm in length.The wires sheaths was accordioned.The complaint was confirmed for device b.A review of the device history record found no non-conformances were noted.A review of complaint history this to be the only reported complaint associated with complaint lot number 7796015.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; device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing and quality controls that may have contributed to this incident.Based on the available information and the investigation results of the returned devices a definitive root cause could not be established.Measures have been initiated to address this failure mode.Cook medical will continue to monitor for similar complaints.As per the quality engineering risk assessment, no further action is required.

• 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6777419
• MDR Text Key: 82165670
• Report Number: 1820334-2017-02297
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482968
• UDI-Public: (01)00827002482968(17)200331(10)7796015
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NGE-022115-MB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/27/2017
• Initial Date FDA Received: 08/09/2017
• Supplement Dates Manufacturer Received: 11/07/2017
• Supplement Dates FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1