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

Catalog Number	NTSED-024115-UDH-MB
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 or Problem Description
It was reported that the wires of the basket of the ncircle delta wire tipless stone extractor became bent and misshapen during usage and multiple passes of the basket using a flexible cystoscope.A new basket was used after this occurred to complete the percutaneous nephrolithotomy (pcnl) procedure.It has been reported that no unintended portion of the device detached inside the patient's body.No additional procedures were required and there were no adverse consequences to the patient due to this occurrence.
Additional Manufacturer Narrative
Evaluation / investigation: a visual inspection and functional testing of the returned device was conducted.In addition, a review of complaint history, the device history record, drawings, instructions for use, quality control data, and specifications was performed.One device was returned for investigation.The device was returned with the handle in the open position.The basket formation is in the closed position, but not retracted, there is 5 mm protruding.The collet knob is tight and secure.The male luer lock adaptor (mlla) is loose.The polyethylene terephthalate tubing (pett) measures 1.5 cm in length.A visual examination noted the support sheath and basket sheath is separated and severed at the nose of the mlla with 5 mm of the coil exposed.There is a kink noted in the basket sheath 2.3 cm from the distal tip of the support sheath.A functional test determined the handle does not actuate the basket formation.The device history record was reviewed and noted 4 non-conforming devices.The non-conformances were unlikely to have been related to the reported failure.A review of complaints history revealed one other complaint associated with lot number 8292659.The complaint was opened for a similar issue and reported by the same customer.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 be non-functional due to damage to the sheath and wire near the handle.A visual examination noted the support sheath and basket sheath is separated and severed at the nose of the mlla with 5 mm of the coil exposed.The kinks prevented the basket from moving within the sheath.All devices are 100% inspected for functionality and integrity before packaging.The ifu contains a caution to not use excessive force to manipulate the device, or damage to the device may occur.The source of the observed damage could not be determined.With the available information, the exact cause of the failure is unknown.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: NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR
• Common Device Name: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7286128
• Report Number: 1820334-2018-00453
• Device Sequence Number: 1824063
• Product Code: FFL
• UDI-Device Identifier: 00827002191112
• UDI-Public: (01)00827002191112(17)201013(10)8292659
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: NTSED-024115-UDH-MB
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/02/2018
• Supplement Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1