BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARADRIVE STEERABLE SHEATH CLEAR

    MDR report key: 21997164 · Received May 9, 2025

    Report

    Report Number
    2124215-2025-30044
    Event Type
    Injury
    Date Received
    May 9, 2025
    Date of Event
    April 17, 2025
    Report Date
    April 6, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRA
    UDI-DI
    00191506043131
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS AMENDED TO UPDATE INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) CODES. INCOMPLETE CODING OF THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH CAPA-8580, WHICH FOCUSED ON IDENTIFYING AND REMEDIATING INCOMPLETE CODING OF EVENTS. INVESTIGATION SUMMARY: BASED ON THE AVAILABLE INFORMATION, ALTHOUGH THE PRODUCT WAS DISPOSED OF AND COULD NOT BE RETURNED, WE HAVE DETERMINED THAT THE PERICARDIAL EFFUSION, HYPOTENSION, AND CARDIAC PERFORATION ARE KNOWN INHERENT RISK OF USE OF THIS DEVICE. DEVICE HISTORY RECORD REVIEW: THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. DEVICE TECHNICAL ANALYSIS: IT WAS INDICATED THE DEVICE IS UNAVAILABLE FOR RETURN; THEREFORE, A TECHNICAL ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. LABELING REVIEW: BASED ON THE INFORMATION PROVIDED, THERE IS NO EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELLED INDICATIONS/INSTRUCTIONS FOR USE. RISK REVIEW: A RISK REVIEW PERFORMED FOR THE FARADRIVE DEVICE CONFIRMED THAT THE EVENT OF CARDIAC TRAUMA AND PERICARDIAL EFFUSION ARE KNOWN EVENTS DEFINED IN THE PRODUCT'S RISK MANAGEMENT DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. PRODUCT RISK BENEFIT INCLUDES CONSIDERATION OF RISK SEVERITY AND RATE, AND THE OVERALL RESIDUAL RISK OF THE FARADRIVE DEVICE IS ACCEPTABLE. INVESTIGATION CONCLUSION: BASED ON THE INFORMATION PROVIDED, THE REPORTED EVENT OF PERICARDIAL EFFUSION, HYPOTENSION, AND CARDIAC PERFORATION ARE KNOWN INHERENT RISKS OF THE FARADRIVE DEVICE. CARDIAC PERFORATION IS CONSIDERED WITHIN THE RISK THRESHOLD FOR CARDIAC TRAUMA. CARDIAC TRAUMA, PERICARDIAL EFFUSION, AND HYPOTENSION ARE EXPECTED PROCEDURAL COMPLICATIONS ADDRESSED WITHIN THE IFU FOR THE FARADRIVE SHEATH. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PULSE FIELD ABLATION (PFA) PROCEDURE USING A FARADRIVE SHEATH THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. PRIOR TO ANY ABLATIONS TAKING PLACE, IT WAS NOTICED THAT THE PATIENT HAD LOW BLOOD PRESSURE. THEY CHECKED INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND CONFIRMED AN EFFUSION WAS PRESENT. THE PROCEDURE WAS CANCELLED AT THIS TIME AND A PERICARDIOCENTESIS WAS PERFORMED. THE PHYSICIAN SUSPECTED A PERFORATION OCCURRED WHEN PLACING THE CS CATHETER OR DURING MANIPULATION OF THE MAPPING CATHETER ("COMING OUT OF THE RIPV HE MIGHT HAVE HAD HIS MAPPING CATHETER SLIGHTING IN THE SHEATH AS HEW AS MANEUVERING TOWARD THE POSTERIOR WALL OUT OF THE RIPV"). THE PATIENT IS EXPECTED TO FULLY RECOVER. THE SHEATH WAS DISPOSED BY THE FACILITY AND WILL NOT BE RETURNED AS THE DEVICE PERFORMED AS EXPECTED DURING THE PROCEDURE AND THERE WERE NO REPORTS OF ANY PERFORMANCE CONCERNS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PULSE FIELD ABLATION (PFA) PROCEDURE USING A FARADRIVE SHEATH THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. PRIOR TO ANY ABLATIONS TAKING PLACE, IT WAS NOTICED THAT THE PATIENT HAD LOW BLOOD PRESSURE. THEY CHECKED INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND CONFIRMED AN EFFUSION WAS PRESENT. THE PROCEDURE WAS CANCELLED AT THIS TIME AND A PERICARDIOCENTESIS WAS PERFORMED. THE PHYSICIAN SUSPECTED A PERFORATION OCCURRED WHEN PLACING THE CS CATHETER OR DURING MANIPULATION OF THE MAPPING CATHETER ("COMING OUT OF THE RIPV HE MIGHT HAVE HAD HIS MAPPING CATHETER SLIGHTING IN THE SHEATH AS HEW AS MANEUVERING TOWARD THE POSTERIOR WALL OUT OF THE RIPV"). THE PATIENT IS EXPECTED TO FULLY RECOVER. THE SHEATH WAS DISPOSED BY THE FACILITY AND WILL NOT BE RETURNED AS THE DEVICE PERFORMED AS EXPECTED DURING THE PROCEDURE AND THERE WERE NO REPORTS OF ANY PERFORMANCE CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475371 FARADRIVE STEERABLE SHEATH CLEAR CATHETER, STEERABLE DRA BOSTON SCIENTIFIC CORPORATION CL13799 00191506043131

    Patients

    Seq Age Sex Outcome Treatment
    1