BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONE CONE

    MDR report key: 11610649 · Received April 2, 2021

    Report

    Report Number
    3005099803-2021-01371
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    March 1, 2021
    Report Date
    June 7, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGO
    UDI-DI
    08714729430223
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. BLOCK H6: DEVICE CODE A040506 CAPTURES THE REPORTABLE EVENT OF COIL PEELED. BLOCK H10: THE RETURNED STONE CONE WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE DISTAL TIP WAS BENT AND DAMAGED, AND THE COATING WAS PARTIALLY REMOVED FROM THE DISTAL TIP AND THE COIL. THE BLUE OUTER SHEATH WAS UNABLE TO MOVE DUE TO THE DAMAGED COATING ON THE COIL. THERE WAS NO EVIDENCE OF MELTING OR SCORCHING AROUND THE DAMAGE, SO IT WAS UNLIKELY DUE TO LASER INTERACTION. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. THE REPORTED EVENT WAS CONFIRMED. BASED ON ALL AVAILABLE INFORMATION, IT IS LIKELY THAT THE USER ENCOUNTERED DIFFICULTY DURING THE PROCEDURE. THE DAMAGE NOTED DURING PRODUCT ANALYSIS WAS LIKELY CAUSED BY INTERACTION WITH OTHER DEVICES DURING THE PROCEDURE. THIS LIKELY COULD HAVE LED TO COATING DAMAGE OF THE DISTAL TIP. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL RETRIEVAL COIL WAS USED IN THE URETER DURING A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6), 2021. DURING THE PROCEDURE, THE STONE CONE DEVICE WAS INSERTED INTO THE URETEROSCOPE. HOWEVER, RESISTANCE WAS NOTED WHEN ATTEMPTING TO STRAIGHTEN THE COIL. THE PHYSICIAN KEPT PUSHING THE STONE CONE TOWARDS THE END OF THE SCOPE BUT THE COIL COULD NOT COME OUT FROM THE DISTAL END OF THE SCOPE. THE STONE CONE WAS REMOVED INSTEAD AND FOUND THE COIL HAS BENT AND PEELED, AS CONFIRMED BY A PHOTO SUBMITTED BY THE CUSTOMER. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONE CONE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL RETRIEVAL COIL WAS USED IN THE URETER DURING A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE STONE CONE DEVICE WAS INSERTED INTO THE URETEROSCOPE. HOWEVER, RESISTANCE WAS NOTED WHEN ATTEMPTING TO STRAIGHTEN THE COIL. THE PHYSICIAN KEPT PUSHING THE STONE CONE TOWARDS THE END OF THE SCOPE BUT THE COIL COULD NOT COME OUT FROM THE DISTAL END OF THE SCOPE. THE STONE CONE WAS REMOVED INSTEAD AND FOUND THE COIL HAS BENT AND PEELED, AS CONFIRMED BY A PHOTO SUBMITTED BY THE CUSTOMER. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONE CONE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506275 STONE CONE DISLODGER, STONE, FLEXIBLE FGO BOSTON SCIENTIFIC CORPORATION M0063903200 08714729430223

    Patients

    Seq Age Sex Outcome Treatment
    1