BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2020487 · Received March 16, 2011

    Report

    Report Number
    2024168-2011-01766
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    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). THE ADDITIONAL PROSTAR AND 2 PROGLIDES OF THE INITIAL MEDWATCH REPORT WERE FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. IT WAS NOT POSSIBLE TO PERFORM A THOROUGH ANALYSIS ON THE PRODUCT AS THE DEVICE WAS NOT RETURNED TO ABBOTT VASCULAR FOR INVESTIGATION. IT SHOULD BE NOTED THAT THE PATIENTS HISTORY OF PERIPHERAL VASCULAR DISEASE, MILD TORTUOSITY AND MILD CALCIFICATION OF THE ARTERIES, AND WEIGHT MAY HAVE CONTRIBUTED TO THE EXPERIENCED EVENT. THE RETURN OF THE DEVICE MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE EXPERIENCED EVENT. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, A SAMPLING OF FINISHED DEVICES IS TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. BASED ON THE INFORMATION AVAILABLE, THE REPORTED DIFFICULTIES EXPERIENCED DURING THE PROCEDURE, APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PRODUCT.

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4): PATIENT OBESITY AND USE IN A CALCIFIED VESSEL THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF BOTH THE PROSTAR XL AND PROGLIDE DEVICES ATTEMPTED ARTERIOTOMY CLOSURE OF A MILDLY TORTUOUS AND MILDLY CALCIFIED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING PRE-CLOSE SUTURE PLACEMENT, THE SUTURE FROM TWO PROSTAR XL DEVICES DID NOT CAPTURE ARTERIAL TISSUE. AN ATTEMPT WAS MADE TO USE TWO PROGLIDE DEVICES TO CLOSE THE 18F ACCESS SITE, BUT BOTH WERE UNSUCCESSFUL. HEMOSTASIS WAS ACHIEVED SURGICALLY. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION. IT WAS BELIEVED THAT THE DEPLOYMENT OF THE FOUR DEVICES AND THEIR ABILITY TO ACHIEVE HEMOSTASIS WAS INFLUENCED BY THE WEIGHT OF THE PATIENT AND THE PREPARATION OF THE TISSUE TRACT NOT BEING LARGE ENOUGH. ACCORDING TO THE PHYSICIAN THERE WAS NO DEVICE PROBLEM. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, 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 910226H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN