BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAZER® II XP

    MDR report key: 2499050 · Received March 21, 2012

    Report

    Report Number
    2134265-2012-01732
    Event Type
    Injury
    Date Received
    March 21, 2012
    Report Date
    February 21, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
    Product Code
    OAD
    PMA / PMN Number
    P020025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SULEIMAN, M, ET AL. ATORVASTATIN FOR PREVENTION OF ATRIAL FIBRILLATION RECURRENCE FOLLOWING PULMONARY VEIN ISOLATION: A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED TRIAL, HEART RHYTHM 2012; 9 (2): 172-178. AGE AT TIME OF EVENT: (B)(6). DEVICE EVALUATION BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME ARTICLE AS MDR #: 2134265-2012-01787. IT WAS REPORTED VIA JOURNAL ARTICLE "ATORVASTATIN FOR PREVENTION OF ATRIAL FIBRILLATION RECURRENCE FOLLOWING PULMONARY VEIN ISOLATION: A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED TRIAL" THAT DURING A ABLATION PROCEDURE FOR TREATMENT OF ATRIAL FIBRILLATION A VESSEL PERFORATION OCCURRED IN ONE PATIENT. THE LEFT ATRIUM (LA) WAS THE TARGET FOR TREATMENT. A NON-BSC NEEDLE AND TWO UNSPECIFIED LONG SHEATHS WERE PLACED IN THE LA. A NON-BSC 10-POLE CIRCULAR MAPPING CATHETER WAS ADVANCED THROUGH ONE OF THE SHEATHS AND POSITIONED INSIDE THE PULMONARY VEIN (PV), WITHIN 5 MM OF THE OSTIUM FOR MAPPING OF PV POTENTIALS. AN UNSPECIFIED ABLATION CATHETER WAS ADVANCED THROUGH THE SECOND SHEATH AND ONE OF TWO POSSIBLE ABLATION TECHNIQUES WAS PERFORMED. THESE ABLATION TECHNIQUES CONSISTED OF EITHER LASSO GUIDED CIRCUMFERENTIAL PV ISOLATION USING THE 5MM BLAZER II XP ABLATION CATHETER FOR ABLATION AND A NON-BSC CATHETER POSITIONED AT THE PV ORIFICE FOR GUIDANCE OR A WIDE-AREA CIRCUMFERENTIAL ABLATION USING A NON-BSC COOL SALINE IRRIGATED CATHETER AND NON-BSC NONFLUROSCOPIC NAVIGATION SYSTEM FOR MAPPING. DURING THE UNSPECIFIED ABLATION PROCEDURE, AN INADVERTENT PUNCTURE OF THE SUBCLAVIAN ARTERY OCCURRED IN ONE PATIENT WHICH REQUIRED SURGICAL REPAIR.

    Description of Event or Problem · 1

    SAME ARTICLE AS MDR ID#: 2134265-2012-01787. IT WAS REPORTED VIA JOURNAL ARTICLE "ATORVASTATIN FOR PREVENTION OF ATRIAL FIBRILLATION RECURRENCE FOLLOWING PULMONARY VEIN ISOLATION: A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED TRIAL" THAT DURING A ABLATION PROCEDURE FOR TREATMENT OF ATRIAL FIBRILLATION A VESSEL PERFORATION OCCURRED IN ONE PATIENT. THE LEFT ATRIUM (LA) WAS THE TARGET FOR TREATMENT. A NON-BSC NEEDLE AND TWO UNSPECIFIED LONG SHEATHS WERE PLACED IN THE LA. A NON-BSC 10-POLE CIRCULAR MAPPING CATHETER WAS ADVANCED THROUGH ONE OF THE SHEATHS AND POSITIONED INSIDE THE PULMONARY VEIN (PV), WITHIN 5 MM OF THE OSTIUM FOR MAPPING OF PV POTENTIALS. AN UNSPECIFIED ABLATION CATHETER WAS ADVANCED THROUGH THE SECOND SHEATH AND ONE OF TWO POSSIBLE ABLATION TECHNIQUES WAS PERFORMED. THESE ABLATION TECHNIQUES CONSISTED OF EITHER LASSO GUIDED CIRCUMFERENTIAL PV ISOLATION USING THE 5MM BLAZER II XP ABLATION CATHETER FOR ABLATION AND A NON-BSC CATHETER POSITIONED AT THE PV ORIFICE FOR GUIDANCE OR A WIDE-AREA CIRCUMFERENTIAL ABLATION USING A NON-BSC COOL SALINE IRRIGATED CATHETER AND NON-BSC FLUOROSCOPIC NAVIGATION SYSTEM FOR MAPPING. DURING THE UNSPECIFIED ABLATION PROCEDURE, AN INADVERTENT PUNCTURE OF THE SUBCLAVIAN ARTERY OCCURRED IN ONE PATIENT WHICH REQUIRED SURGICAL REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAZER® II XP CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) M0044500THMK20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention