MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION LITHOTRIPSY EXTRACTION BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

Catalog Number FS-LXB-3X6

Device Problems Break (1069); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant product: conquest ttc lithotriptor cable (unknown reference part number). Investigation evaluation: our evaluation of the product said to be involved confirmed the report. The distal tip of the basket separated from the device and was not provided with the return. The drive wire cable and sheath had been cut near the handle of the device. The drive wire cables of the baskets were no longer inside of their sheath. The drive wire cable and sheath have several kinks throughout. Particularly, the drive wire cable has several larger kinks approximately 89 cm to 98 cm from the distal end. A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed. The device history record for the lot number said to be involved was reviewed. A discrepancy or anomaly was not observed with the product that was released for distribution. Investigation conclusion: we could not conduct a complete investigation due to the condition of the returned device said to be involved. The distal metal tip of the device had separated from the basket and was not provided with the return. The reporter indicated this device was used in a bench top demonstration where the device was being tested to failure. The reporter clarified that the user wanted to test the device to failure in order to learn in which way the device would fail. The information for use (ifu) for the soehendra lithotriptor handle has the following intended use, "this device is used to mechanically crush stones in the biliary duct when other methods of endoscopic removal have failed. " the ifu for the fusion lithotripsy basket has the following intended use, "this device is used for endoscopic removal of biliary stones and foreign bodies. " both ifus further state, "do not use this device for any purpose other than stated intended use. " the reporter indicated the user "put a pen to simulate the stone in the basket" and then tested the device to failure. However, an ink pen has a very different shape, texture, and material composition than a biliary stone. The ifu for the soehendra lithotriptor handle states the following, "due to varying compositions of biliary stones, stone fracture may not be possible. If stone cannot be fractured, continued rotation of handle may cause basket wire to break, requiring surgical intervention. " the ifu for the soehendra lithotriptor handle states the following, "to fracture stone, apply pressure by slowly rotating handle. Note: slow, constant pressure is often most effective method of fracturing a stone. Sudden release of pressure may indicate fracture of stone, fracture of basket, or loss of stone from basket. " during the teleconference call, the reporter indicated that for these baskets "the lithotriptor handle was rotated rather quickly. " the ifu for the fusion lithotripsy basket indicates, "withdraw basket into sheath while maintaining entrapment. Caution: if difficulty is encountered when removing basket from duct, do not use excessive force. Moderate force may be applied by closing handle to manually fracture stone. If passage is still restricted, surgical intervention may be necessary. " prior to distribution, all fusion lithotripsy extraction baskets are subjected to a visual inspection and functional testing to ensure device integrity. A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment. Corrective action: a review of the complaint history was conducted. The likelihood of occurrence is considered rare. Corrective action is not warranted at this time based on the quality engineering risk assessment. Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available. Additional comments regarding this report: based on the information provided of abnormal use [the device was used off label] and the instructions for use were not followed, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

Event Description

In preparation for testing, the user selected a cook fusion lithotripsy extraction basket. At the testing, the cable in the catheter got torn apart. The following additional information was provided on 5/12/17: the cable ripped in the catheter instead of at the tip. We put a pen to simulate the stone in the basket and put the handle in the alliance handpump from boston scientific and closed the basket. After we cut off the handle and inserted the cable into the cook conquest ttc and soehendra lithotriptor handle the cable ripped inside the catheter instead of at the tip. Per a teleconference on 5/15/2017 with the area representatives the user was "under the impression that the basket would break at the tip during mechanical lithotripsy. " the product was used prior to use in a teaching environment to show the user what the product would do with a pen to simulate the stone in the basket. During the discussion it was disclosed that "the soehendra lithotriptor handle was cranked pretty fast. ".

• Brand Name: FUSION LITHOTRIPSY EXTRACTION BASKET
• Type of Device: FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 6578054
• Report Number: 1037905-2017-00289
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482784
• UDI-Public: (01)00827002482784(17)190627(10)W3734378
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: FS-LXB-3X6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/25/2017
• Device Age: 9 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial