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

Catalog Number NTSE-022115-UDH

Device Problem Detachment Of Device Component (1104)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 09/12/2017

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

The area representative reported during a ureteroscopy procedure performed on (b)(6) 2017, the ncircle tipless stone extractor was used to retrieve a stone.While in use, the basket broke off at the neck of the basket leaving the basket in the patient.A second ncircle tipless stone extractor was used and it also broke off in the same way.When the third ncircle tipless stone extractor was put into use, it did not break off however, it would not work properly and it had to be disassembled to remove it from the patient.The procedure could not be completed.The patient had to come back to have basket fragments removed and the ureteroscopy procedure completed.The basket fragments were removed using a different device.There were no adverse consequences to the patient during the interventional surgery.Additional event and patient information has been requested.Three related reports have been filed to capture each of the three device malfunctions reported to occur during one procedure.Mfr.Report # 1820334-2017-03515 captures the first basket, mfr.Report # 1820334-2017-03517 captures the second basket and mfr.Report # 1820334-2017-03519 captures the third basket used in the procedure.

Manufacturer Narrative

Evaluation / investigation: a review of drawings, documentation, manufacturing instructions, quality control and specifications was performed.A visual inspection and functional testing was also conducted.Two ncircle tipless stone extractors were returned for evaluation.The extractors were returned tangled up together.The handles were disassembled.Basket #1: the handle was detached.The male luer lock adaptor (mlla) and collet were detached.The polyethylene terephthalate tubing (pett) was not returned.The basket sheath measured 112.7 cm.The support sheath and the basket sheath are still adhered.The basket formation was severed and not returned for evaluation.The coil assembly could be manually actuated.There is 1.5 cm of coil that extends from the basket sheath.Basket #2: this device was severely tangled.The handle was detached and disassembled and the pett was not returned.The basket sheath measured 115 cm.The cannulated handle was bent 10 cm from the proximal end.The coil was stretched and tangled.The basket formation was severed and was not returned for evaluation.Attempts have been made to obtain additional information with little success.The two returned devices were used in the same procedure and encountered the same device failure.It is not known if both devices were from the same lot.Both returned devices appear to have met resistance beyond their 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 lot numbers of the involved devices were not provided.Therefore, a review of the device history record and lot complaint history was not able to be performed.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: 6936905
• MDR Text Key: 89110955
• Report Number: 1820334-2017-03515
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-022115-UDH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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