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

Catalog Number NGE-022115-MB

Device Problems Stretched (1601); Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2017

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 user facility reported the ncircle tipless stone extractor was used during a stone extraction procedure.After using the device to extract kidney/ureter stones 2 or 3 times, the inner wire/sheath had stretched and the basket would no longer close.The open basket could not be pulled into the ureteroscope.The surgeon removed the basket and the ureteroscope together from the patient and cut the basket sheath to remove the extractor from the ureteroscope.Another ngage nitinol stone extractor was utilized to complete the procedure.As reported, there were no adverse effects to the patient due to this occurrence.

Manufacturer Narrative

One ngage nitinol stone extractor was received for an evaluation.The device was returned with the handle in the closed position.A visual examination noted the basket assembly has been severed 4 cm from the distal tip-part.The cannula is still adhered.One wire protruding from offset coil is less than 1 mm.The wire has broken off from the offset coil.One wire is protruding the coil assembly approximately 5 mm.The polyethylene terephthalate tubing (pett) measures 3.4 cm in length.The basket sheath has no kinks but has been severed in four places.There is a 4 mm piece of basket sheath that is severed; one piece measures 5 cm, one piece measures 1mm and then the main segment.The 5 cm segment has two wires extending; one at 6 mm from the point of separation and one 2 mm from the point of separation on the proximal end.The braiding is exposed from the basket sheath on the proximal end.The distal end of the 5 cm segment has the all the basket wires pulled out.The basket formation is flat and twisted.The collet knob is tight and secure.The male luer lock adaptor (mlla) is tight.The handle actuates the basket assembly.The complaint is confirmed.It appears this device has met resistance beyond its intended design.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record showed there were no non-conformances identified during the manufacturing process.A review of complaint history for this product/lot number combination revealed no other complaints have been received.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• 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: 6768213
• MDR Text Key: 81852321
• Report Number: 1820334-2017-02165
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482968
• UDI-Public: (01)00827002482968(17)200309(10)7737533
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2017
• 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