BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARADRIVE STEERABLE SHEATH CLEAR

    MDR report key: 24320454 · Received February 12, 2026

    Report

    Report Number
    2124215-2026-07908
    Event Type
    Injury
    Date Received
    February 12, 2026
    Date of Event
    January 14, 2026
    Report Date
    April 10, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRA
    UDI-DI
    00191506042516
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2A: COMMON DEVICE NAME: PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH IRREVERSIBLE ELECTROPORATION; REPORTED HERE AS THE COMMON DEVICE NAME EXCEEDED THE CHARACTER LIMIT FOR DESIGNATED FIELD. INVESTIGATION SUMMARY: WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES, THERE WERE NO ALLEGATIONS OF A QUALITY OR MANUFACTURING DEFICIENCY LEADING TO THE ADVERSE EVENT AS REPORTED TO BSC, AND THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AT THIS TIME. DEVICE HISTORY REVIEW: THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. LABELING REVIEW: BASED ON THE INFORMATION PROVIDED, THERE IS NO EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELLED INDICATIONS. RISK REVIEW: A REVIEW OF THE FARADRIVE STEERABLE SHEATH (CLEAR) OUS RISK DOCUMENTATION WAS COMPLETED AND CONFIRMED THAT THE EVENT OF HEMORRHAGE WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF THE KNOWN INHERENT RISK OF DEVICE CAUSE CODE WAS SELECTED BASED ON THE INFORMATION PROVIDED WITHIN THE EVENT DESCRIPTION, AND SUPPORTING EVIDENCE THAT CAME TO THIS CONCLUSION.

    Additional Manufacturer Narrative · 0

    D2A: COMMON DEVICE NAME: PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH IRREVERSIBLE ELECTROPORATION; REPORTED HERE AS THE COMMON DEVICE NAME EXCEEDED THE CHARACTER LIMIT FOR DESIGNATED FIELD. IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BLEEDING AT THE PUNCTURE SITE. FOLLOWING A PULSED FIELD ABLATION (PFA) PROCEDURE WHERE A FARADRIVE STEERABLE SHEATH (CLEAR) WAS SELECTED FOR USE, THE PATIENT EXPERIENCED BLEEDING AT THE PUNCTURE SITE. ORAL MEDICATION ADJUSTMENT AND PROLONGED HOSPITALIZATION WERE REQUIRED. NO DIAGNOSTIC TESTS WERE PERFORMED IN RELATION WITH THIS AE. NO DEVICE ISSUES WERE REPORTED. ITS UNKNOW IF THE DEVICE WILL RETURN FOR LABORATORY ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BLEEDING AT THE PUNCTURE SITE. FOLLOWING A PULSED FIELD ABLATION (PFA) PROCEDURE WHERE A FARADRIVE STEERABLE SHEATH (CLEAR) WAS SELECTED FOR USE, THE PATIENT EXPERIENCED BLEEDING AT THE PUNCTURE SITE. ORAL MEDICATION ADJUSTMENT AND PROLONGED HOSPITALIZATION WERE REQUIRED. NO DIAGNOSTIC TESTS WERE PERFORMED IN RELATION WITH THIS AE. NO DEVICE ISSUES WERE REPORTED. ITS UNKNOWN IF THE DEVICE WILL RETURN FOR LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381612 FARADRIVE STEERABLE SHEATH CLEAR CATHETER, STEERABLE DRA BOSTON SCIENTIFIC CORPORATION CL14518 00191506042516

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R