BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 3954954 · Received July 24, 2014

    Report

    Report Number
    2024168-2014-04743
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 30, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INDICATION FOR USE, USED TO ADDRESS THAT THE PROSTAR XL 10F DEVICE WAS USED IN A 6F RIGHT COMMON FEMORAL ARTERY. THE INSTRUCTIONS FOR USE STATES: THE PROSTAR XL 10F PVS SYSTEM IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURES FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SIE AND REDUCING THE TIME TO HEMOSTASIS AND TIME TO AMBULATION (PATIENT WALKS 10 FEET) OF PATIENTS WHO HAVE UNDERGONE CATHETERIZATION PROCEDURES USING 8.5F TO 10F SHEATHS. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DEVICE OPERATES DIFFERENTLY THAN EXPECTED WAS CONFIRMED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THIS LOT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE INDICATED THERE HAD BEEN NO SIMILAR INCIDENTS REPORTED FOR THIS LOT. IT WAS REPORTED THAT THE DEVICE WAS USED WITH A 6F SHEATH. THE INSTRUCTIONS FOR USE, STATES: 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 10 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 PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR PROCEDURE, SUTURE PLACEMENT USING THE PRECLOSE TECHNIQUE WAS ATTEMPTED IN THE RIGHT COMMON FEMORAL ARTERY USING A PROSTAR XL DEVICE. REPORTEDLY, AN UNKNOWN FAILURE OCCURRED. THE SUTURES OF A SECOND PROSTAR XL DEVICE WERE SUCCESSFULLY PLACED USING THE PRECLOSE TECHNIQUE. THE ARTERIOTOMY WAS 6F. THE SHEATH WAS UPSIZED TO 12F FOR THE AAA PROCEDURE. AFTER THE COMPLETION OF THE AAA PROCEDURE THE SUCCESSFULLY PREPLACED SUTURES OF THE SECOND PROSTAR XL DEVICE ACHIEVED HEMOSTASIS. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT DELAY IN THE PROCEDURE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PROSTAR XL DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434625 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40418K1

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention SHEATH: 6F, 12F, HEPARIN