BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2853027 · Received November 30, 2012

    Report

    Report Number
    2024168-2012-07577
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. (B)(4): THE SAFETY AND EFFECTIVENESS OF THE PROSTAR XL PVS SYSTEM HAVE NOT BEEN ESTABLISHED IN THE FOLLOWING PATIENT POPULATIONS: PATIENTS WITH INTRODUCER SHEATHS LESS THAN 8.5F OR GREATER THAN 24F DURING THE CATHETERIZATION PROCESS. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT WAS REPORTED THAT AN 8F SIZED INTRODUCER SHEATH WAS USED. AS PER THE INDICATIONS FOR USE, THE PROSTAR XL 10F PVS SYSTEM IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURES FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE AND REDUCING THE TIME TO HEMOSTASIS AND TIME TO AMBULATION (PATIENT WALKS TEN FEET) OF PATIENTS WHO HAVE UNDERGONE CATHETERIZATION PROCEDURES USING 8.5F TO 10F SHEATHS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS SUCCESSFUL IN THE LEFT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) INTERVENTIONAL PROCEDURE. THE ARTERIOTOMY WAS 8F AND WAS UPSIZED TO 16F FOR THE AAA PROCEDURE. REPORTEDLY, AFTER THE AAA PROCEDURE, DURING THE ARTERIOTOMY CLOSURE, THE PUNCTURE WAS NEAR THE INGUINAL LIGAMENT AND THE KNOTS COULD NOT BE ADVANCED TO THE ARTERY WALL. A SURGICAL CUT DOWN WAS PERFORMED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. IT WAS REPORTED THAT THE PHYSICIAN IS IN-TRAINING IN THE USE OF THE PROSTAR XL DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20227K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 8F, 16FHEPARIN