BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1854403 · Received September 30, 2010

    Report

    Report Number
    2953144-2010-02348
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    May 12, 2010
    Report Date
    May 12, 2010
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED DEPLOYED. THE SUTURES AND NEEDLES WERE NOT REC'D WITH THE DEVICE. THE SHEATH WAS STRETCHED AND TORN DISTAL TO THE CRIMP-DIMPLED RING. IT WAS REPORTED THAT THE OUTER SHEATH WAS REMOVED WHILE ADVANCING THE WHITE SUTURE, WHICH IS AN INCORRECT TECHNIQUE AND COULD RESULT IN THE REPORTED EXPERIENCE. THE INSTRUCTIONS FOR USE, UNDER SUTURE MANAGEMENT, INSTRUCT THE USER TO WITHDRAW THE PROSTAR XL DEVICE WHILE MAINTAINING ACCESS TO THE SUTURES EXITING THE HUB. CREATE A BOWSTRING EFFECT WITH THE EXPOSED SUTURE(S) BY BENDING THE PROSTAR XL DEVICE SHEATH AWAY FROM THE OPERATOR AND APPLYING TENSION TO THE SUTURE ENDS EXITING THE HUB. THIS ENSURES THAT THE SUTURES ARE NOT TIED AROUND THE SHEATH. THE KNOW ADVANCEMENT IS DONE LATER IN THE PROCEDURE. IT WAS REPORTED THAT THE DEVICE WAS USED IN THE SUPERFICIAL FEMORAL ARTERY AND A 14F PROCEDURAL SHEATH WAS USED FOR THE CATHETERIZATION PROCEDURE. THE INSTRUCTIONS FOR USE STATE UNDER INDICATIONS FOR USE, THE PROSTAR XL PERCUTANEOUS PVS SYSTEM IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURES FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE. ADDITIONALLY, THE INSTRUCTIONS FOR USE STATE DO NOT USE THE PROSTAR XL PVS SYSTEM IF THE PUNCTURE SITE IS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY OR THE PROFUNDA FEMORIS ARTERY, SINCE SUCH PUNCTURE SITES MAY RESULT IN A PSEUDOANEURYSM, INTIMAL DISSECTION, OR AN ACUTE VESSEL CLOSURE (THROMBOSIS OF SMALL ARTERY LUMEN). PERFORM A FEMORAL ANGIOGRAM TO VERIFY THE LOCATION OF THE PUNCTURE SITE. THE SHEATH WAS TORN FROM THE DISTAL CRIMP RING DURING DEPLOYMENT, WHICH INDICATES THE DEVICE WAS SUBJECTED TO FORCES EXCEEDING THE DESIGN OF 5LBS TENSILE STRENGTH AT THE SHAFT TO SHEATH DIMPLED CRIMPED RING. THE INSTRUCTIONS FOR USE UNDER PRECAUTIONS INSTRUCTS THE USER TO NOT ADVANCE OR WITHDRAW THE PROSTAR XL DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THAT RESISTANCE HAS BEEN DETERMINED. EXCESSIVE FORCE USED TO ADVANCE OR TORQUE THE PROSTAR XL DEVICE SHOULD BE AVOIDED AS IT MAY LEAD TO SIGNIFICANT ARTERIAL DAMAGE AND/OR BREAKAGE OF THE DEVICE, WHICH MAY NECESSITATE INTERVENTION AND/OR SURGICAL REMOVAL OF THE DEVICE AND ARTERIAL REPAIR. BASED ON THE FINDINGS, THE ROOT CAUSE FOR THE REPORTED EXPERIENCE IS DUE TO A FAILURE TO FOLLOW INSTRUCTIONS AND INCORRECT TECHNIQUE/PROCEDURES. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN IN-TRAINING IN THE USE OF THE PROSTAR XL DEVICE, ACHIEVED ARTERIOTOMY CLOSURE OF A MILDLY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHILE ADVANCING THE "WHITE KNOT, THE OUTER SHEATH WAS REMOVED, AND THE SUTURE WAS PULLED OUT FROM THE VESSEL. IT WAS BELIEVED THAT DUE TO THE OUTER SHEATH BEING REMOVED, THERE WAS A LACK OF SMOOTH TRANSITION AND TENSION ON THE WHITE SUTURE, WHICH CAUSED THE SUTURE TO BE PULLED THROUGH THE VESSEL WALL." HEMOSTASIS WAS ACHIEVED WITH THE GREEN SUTURE ALONE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE MGB ABBOTT VASCULAR - VASCULAR SOLUTIONS NA 86020-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK HEPARIN| PROCEDURAL SHEATH 14F