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

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 06/20/2017

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

It was reported that prior to performing a procedure the operator noticed that a portion of ngage nitinol stone extractor basket was detached near the handle section.The device did not come in contact with patient.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: a visual inspection and functional testing of the returned device was performed during the investigation.A review of complaint history, the device history record, documentation, quality control data and specifications was also conducted.No issues were identified that are related to the reported complaint.One device was returned for evaluation.A visual examination noted the device was returned with the unidex handle (udh) in between the open and closed positions.A visual examination noted the support sheath and the basket sheath are still adhered, but the basket sheath is severed at the base of the support sheath.There is a gap between the basket sheath and the distal tip of the of the support sheath exposing 6 mm of coil.Some of the braiding on the basket sheath was noted to have come loose.A functional test noted the udh handle does not actuate the basket formation.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.A small bend was found in the basket sheath that measures 15.5 cm from the distal tip of the basket sheath.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 found no non-conformances associated with the complaint device lot number.A review of complaint history found this to be the only complaint associated with complaint lot number 7707042.Based on the provided information a definitive root cause cannot be established.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: 6718077
• MDR Text Key: 80193870
• Report Number: 1820334-2017-01595
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482951
• UDI-Public: (01)00827002482951(17)200227(10)7707042
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2018

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NGE-017115-MB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2017
• Initial Date FDA Received: 07/17/2017
• Supplement Dates Manufacturer Received: 01/19/2018
• Supplement Dates FDA Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2017
• 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