BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2151906 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04786
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. AGE - THE PATIENT REPORTEDLY IS ELDERLY. WEIGHT - THE PATIENT REPORTEDLY IS VERY THIN. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). A THOROUGH ANALYSIS ON THE PRODUCT COULD NOT BE PERFORMED BECAUSE IT WAS NOT RETURNED FOR INVESTIGATION. WITHOUT THE PRODUCT TO EXAMINE, NO DETERMINATION CAN BE MADE AS TO THE CONTRIBUTING FACTORS THAT CAUSED THE REPORTED DISCREPANCY. IT SHOULD BE NOTED THAT THE REPORTED USE OF PERCLOSE A-T DEVICE AFTER THE USE OF A SHEATH LARGER THAN 8 FR IS NOT CONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU). THE IFU READS: THE PERCLOSE A-T 6F SMC SYSTEM IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5F TO 8F SHEATHS. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THE DEVICES ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY MANUFACTURING RELATED NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENT REPORTED FOR CONTINUED BLEEDING FOLLOWING THE OFF LABEL USE OF THE DEVICE FOR THIS LOT. BASED ON THE INFORMATION AVAILABLE, THE INSPECTION CRITERIA AND THE REVIEW OF THE LOT HISTORY RECORD, THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER THE SUTURES WERE "TIED AND LOCKED" MANUAL ARTERIAL COMPRESSION WAS REQUIRED TO ACHIEVE HEMOSTASIS. A 9FR PROCEDURAL SHEATH WAS USED DURING THE PROCEDURE. THE PHYSICIAN IS REPORTEDLY PROFICIENT IN THE USE OF THE PERCLOSE AT DEVICE. NO CLINICALLY SIGNIFICANT DELAY IN THE INTERVENTIONAL PROCEDURE WAS REPORTED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 030156H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 9 FR ARROW SHEATH