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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. ".
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Manufacturer (Section D)
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
scottie fariole
4900 bethania station rd
winston-salem, NC 27105
MDR Report Key6578054
Report Number1037905-2017-00289
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002482784
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
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 Received05/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberFS-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 Date04/25/2017
Device Age9 MO
Event Location Hospital
Date Manufacturer Received04/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial