BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2141236 · Received June 27, 2011

    Report

    Report Number
    2024168-2011-04491
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 2, 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). WITHOUT THE PRODUCT A PHYSICAL EXAMINATION COULD NOT BE PERFORMED, WHICH LIMITED THE SCOPE OF THE INVESTIGATION. NO DETERMINATION CAN BE MADE AS TO THE CONTRIBUTING FACTORS TO THE REPORTED DISCREPANCY. A SUTURE MAY FAIL TO PENETRATE THE VESSEL WALL DUE TO A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO USER TECHNIQUE, OPERATIONAL CONTEXT, ANATOMICAL CONDITIONS, OR A MANUFACTURING ANOMALY. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING AND A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. IT SHOULD BE NOTED THAT THE REPORTED USE OF A PERCLOSE A-T DEVICE IN AN ARTERY WHERE A SHEATH LARGER THAN 8 FR WAS USED IS NOT CONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU). THE IFU STATES: THE PERCLOSE A-T 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. ADDITIONALLY, TWO UNUSED REPRESENTATIVE SAMPLES WITH THE SAME LOT NUMBER AS THE COMPLAINT DEVICE WERE RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED AND THE DEVICES PASSED WITH ACCEPTABLE RESULTS. NO MALFUNCTION OR ABNORMAL OBSERVATIONS WERE DETECTED. A ROOT CAUSE FOR THE COMPLAINT DEVICE REPORTED EXPERIENCE COULD NOT BE DETERMINED, BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED SAMPLES. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER SIMILAR INCIDENTS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. DEVICE (B)(4) (9F SHEATH WAS USED RATHER THAN 5F TO 8F). THE OTHER PERCLOSE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL (CAROTID) PROCEDURE USING THE PERCLOSE AT DEVICE WITH A 9F SHEATH. REPORTEDLY, THE SUTURE FAILED TO PENETRATE THE VESSEL WALL BECAUSE OF THE SHEATH SIZE USED. INFORMATION PROVIDED INDICATES A SECOND PERCLOSE AT DEVICE WAS USED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. IT WAS ALSO REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PERCLOSE AT DEVICE. 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 020336H

    Patients

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