BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2222504 · Received August 25, 2011

    Report

    Report Number
    2024168-2011-05935
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THAT THE NEEDLE SLOTS AND SUTURE PORTS WERE NORMAL. THERE WAS NO ABNORMAL OBSERVATION FOUND ON THE RETURNED DEVICE THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A SUTURE BREAK MAY OCCUR IF THE OPERATOR USES EXCESSIVE SUTURE TENSION WHEN ADVANCING THE KNOT; HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE WHITE SUTURE WAS NOT RETURNED AND NO DEFINITIVE CAUSE COULD BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO AN INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS SUCCESSFUL IN A COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. THE ARTERIOTOMY WAS 6F AND THE VESSEL WAS MILDLY CALCIFIED. DURING THE AAA PROCEDURE THE SHEATH WAS UPSIZED TO 20F. REPORTEDLY, AFTER THE AAA PROCEDURE DURING THE ARTERIOTOMY CLOSURE DURING ADVANCING THE KNOT, THE WHITE SUTURE BROKE. THE GREEN KNOT WAS ADVANCED COMPLETELY BUT HEMOSTASIS WAS NOT ACHIEVED. SURGICAL INTERVENTION WAS REQUIRED TO CLOSE THE ARTERY. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PERCLOSE PROGLIDE 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 050086H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F AND 20FHEPARIN