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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Type  Injury  

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 during an intended ureteroscopy procedure, a part of the wire deployed from the ncircle tipless stone extractor basket sheath.The physician recovered the deployed part of wire by using another ncircle tipless stone extractor through the scope.No unintended section of the device remained inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).A review of the manufacturing instructions and quality control was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.The lot number of the device is not known; accordingly a review of the device history record could not be conducted.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

Event Description

It was reported that during a ureteroscopy procedure, a part of the wire deployed from the ncircle tipless stone extractor basket sheath.The physician recovered the deployed part of wire by using another extractor through the scope.No unintended section of the device remained inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Evaluation / investigation: a review of the device history record, documentation, drawings, manufacturing instructions, quality control, and specifications was performed.A visual inspection and functional testing of the returned device was also conducted.One ncircle tipless stone extractor was returned for evaluation.The device was returned with the handle in the open position.The collet knob is tight and secure.The male luer lock adaptor (mlla) is loose.The polyethylene terephthalate tubing (pett) measures 2.7 cm in length.The support sheath and the basket sheath are still adhered.The basket formation was returned severed from the basket sheath.The basket sheath has a signification kink 65 cm from the point of separation.The basket sheath is smashed 2 mm from the distal tip.The basket formation was returned attached to the cannula with 5 mm of nitinol wire protruding at the proximal end of cannula.A visual examination noted that two wires are severed at 1 mm from the knot.One of the wires is kinked in two location, 5 mm and 8 mm from the knot, respectively.There were scrape marks noted on the basket sheath 42.9 cm from the distal tip section measures 1.7 cm in length.The other wire is secure.The wire with the kinks appears to have been caught on something or pulled.Also, returned was 3.4 cm of the grasper used to retrieve basket.It appears the device 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.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 device history record review was performed and noted there was one non-conformance identified for a device that does not function.This device was scrapped.A review of complaint history for the device/lot combination found there have been no other complaints received.Based on the provided information and the investigation evaluation a definitive root cause for the reported issue could not be determined.Measures have been initiated to address this failure mode.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 TIPLESS 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: 6589039
• MDR Text Key: 75887916
• Report Number: 1820334-2017-01056
• Device Sequence Number: 1
• Product Code: FFL
• 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,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NTSE-022115-UDH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2016
• 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
• Patient Outcome(s): Required Intervention