BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIRANHA

    MDR report key: 18935658 · Received March 19, 2024

    Report

    Report Number
    2124215-2024-16007
    Event Type
    Injury
    Date Received
    March 19, 2024
    Date of Event
    January 1, 2022
    Report Date
    March 19, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    UDI-DI
    08714729302599
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT EVENT ONSET DATE IS UNKNOWN. THE PROVIDED EVENT DATE OF (B)(6) 2022, WAS CHOSEN AS THE BEST ESTIMATE BASED ON THE PROCEDURE WHICH HAPPENED SOMETIME IN 2022. BLOCKS D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: PATIENT CODE E060103 CAPTURES THE REPORTABLE EVENT OF ATRIAL FLUTTER. PATIENT CODE E060109 CAPTURES THE REPORTABLE EVENT OF TACHYCARDIA. IMPACT CODE F12 CAPTURES THE REPORTABLE EVENT OF SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA BIOPSY FORCEPS WAS USED DURING A URETEROSCOPY WITH BIOPSY AND ABLATION OF THE RIGHT LOWER CALYX TUMOR PROCEDURE PERFORMED SOMETIME IN 2022. DURING THE PROCEDURE, THE ACQUISITION OF THE BIOPSY SPECIMEN WAS ADEQUATE. POST-PROCEDURE, THE PATIENT BECAME TACHYCARDIC WITH A NEW ATRIAL FLUTTER. THE PATIENT CHOSE TO BE DISCHARGED AGAINST MEDICAL ADVICE (AMA) ONE (1) DAY POST-PROCEDURE (POD01). PER OPERATIVE NOTES, A NON-BOSTON SCIENTIFIC FLEXIBLE URETEROSCOPE WAS USED WITH A NO-TOUCH TECHNIQUE AND FOUND NO LESIONS IN THE URETER. THERE WAS THE BEGINNING OF CARPET-LIKE RED VELVETY TUMORS INVOLVING ONE OF THE LOWER POLE CALYCES. THERE WAS A NARROW MID-CALYX INFUNDIBULUM WITH A NECROTIC TUMOR VISIBLE INSIDE AND AN UPPER POLE THAT APPEARED TO HAVE A DEAD TUMOR AND NO NEW DISEASE. DILATION OF THE MID-CALYX INFUNDIBULUM WAS DONE WITH A DILATING CATHETER TO 10F TO PERMIT ENTRY INTO IT. SELECTIVE CYTOLOGY AND BIOPSY OF THE TUMOR WERE DONE, AND THULIUM LASER ABLATION OF THE TUMOR WAS ACCOMPLISHED. THE NECROTIC UPPER CALYCEAL TUMOR WAS BIOPSIED AND LASER RESECTED AS WELL, BUT THE LOWER CALYX TUMOR WAS EXTENSIVE, AND VISUALIZATION WAS POOR DUE TO SEVERE ANGULATION. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS SERIOUS, WAS NOT RELATED TO THE DEVICE, AND CAUSALLY RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536843 PIRANHA FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC CORPORATION M0065051600 08714729302599

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other