BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE SUTURE MEDIATED CLOSURE

    MDR report key: 3020760 · Received March 26, 2013

    Report

    Report Number
    2024168-2013-01712
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    July 23, 2012
    Report Date
    March 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHEATH: 5F TO 8F. OTHER: BIVALIRUDIN, GLYCOPROTEIN IIB/IIIA INHIBITOR, HEPARIN, CLOPIDOGREL, TICLOPIDINE. THE ARTICLE WAS PUBLISHED ONLINE ON (B)(4) 2012. IT IS INDICATED THAT THE DEVICES ARE NOT RETURNING FOR EVALUATION. THIS INCIDENT REPORTED ONLY PATIENT EFFECTS WITH NO ALLEGATION OF A DEVICE ISSUE AND, AS SUCH, IS NOT ON ITS OWN AN INDICATION OF A PRODUCT DEFICIENCY. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. (B)(4).

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED ON REVIEW OF THE ARTICLE "ARTERIOTOMY CLOSURE DEVICE SAFETY AFTER PERCUTANEOUS CORONARY INTERVENTION IN THE DIRECT THROMBIN INHIBITOR ERA: A COMPARATIVE STUDY." IT WAS REPORTED THAT A SINGLE (B)(4) STUDY IDENTIFIED 14,354, PATIENTS WHO UNDERWENT PERCUTANEOUS CORONARY INTERVENTION OVER AN EIGHT YEAR PERIOD, 2000 TO 2008. THE PERCLOSE DEVICE WAS USED ON 4,586 PATIENTS. THE FAILURE METHODS AND NUMBER OF DEVICE FAILURES WAS NOT REPORTED. OF THE 4,586 PERCLOSE DEVICE PATIENTS, 401 HAD COMPLICATIONS. CLINICAL OUTCOMES WERE AS FOLLOWS: 70 HEMATOMA GREATER THAN 5 CM; 1 AV FISTULA; 6 PSEUDOANEURYSM; 16 RETROPERITONEAL BLEED; 64 TRANSFUSION; 25 BLEEDING; 2 VASCULAR OCCLUSION; 5 INFECTION; 35 MECHANICAL COMPRESSION; 177 ANY COMPLICATION. ADDITIONALLY 3 PATIENTS REQUIRED VASCULAR SURGERY (TYPE OF CLOSURE DEVICE FOR THESE PATIENTS WAS NOT PROVIDED). NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123285 PERCLOSE SUTURE MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CONCOMITANT MEDICAL DEVICES