BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2760980 · Received September 26, 2012

    Report

    Report Number
    2024168-2012-06076
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 11, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. DEVICE CODE - THE PROSTAR XL 10 FR 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 OF PATIENTS WHO HAVE UNDERGONE CATHETERIZATION PROCEDURES USING 8.5 FR TO 24 FR SHEATHS. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER PROSTAR XL REFERENCED DEVICE IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SUTURE NOT ATTACHED TO THE NEEDLE WAS CONFIRMED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ADDITIONALLY, DURING VISUAL INSPECTION, CLAMP MARKS FOUND ON THE SUTURE AND MARKER TUBES WERE OBSERVED. THE CAUSE FOR THE REPORTED EVENT WAS DETERMINED TO BE DUE TO USE ERROR. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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 ATTEMPTED WITH THE PROSTAR XL IN THE LEFT COMMON FEMORAL ARTERY USING THE PRE-CLOSURE TECHNIQUE PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE. THE ARTERIOTOMY WAS AN 8 FR AND THE VESSEL WAS DESCRIBED AS NOT CALCIFIED AND NOT TORTUOUS. REPORTEDLY, DURING NEEDLE DEPLOYMENT TWO NEEDLES WITH GREEN SUTURE TIPS WERE NOT DEPLOYED. THE PHYSICIAN PERFORMED NEEDLE-BACK DOWN AND USED A SECOND PROSTAR XL. DURING NEEDLE DEPLOYMENT ALL NEEDLES EMERGED AT THE TOP OF THE BARREL AND WHEN AN ANTERIOR NEEDLE WAS COMPLETELY REMOVED FROM THE HUB IT DID NOT HAVE THE GREEN SUTURE ATTACHED TO THE NEEDLE. THE PHYSICIAN PERFORMED NEEDLE-BACK DOWN AND USED A THIRD PROSTAR XL. THE THIRD PROSTAR XL WAS DEPLOYED WITHOUT COMPLICATION AND THE SUTURES WERE SET ASIDE FOR THE TAVI PROCEDURE. THE SHEATH SIZE REMAINED AN 8 FR TO PERFORM THE INDEX PROCEDURE. AFTER COMPLETION OF THE INDEX PROCEDURE HEMOSTASIS WAS ACHIEVED WITH THE DEPLOYED PROSTAR XL SUTURES. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTEDLY 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
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20227K1

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention SHEATH: 8 FR.