BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2063614 · Received April 19, 2011

    Report

    Report Number
    2024168-2011-02757
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THAT THE HANDLE AND THE POSTERIOR LATERAL NEEDLE WERE IN BACKDOWN POSITION. THERE WERE WHITE SUTURE TAILS EXPOSED AT THE GUIDE AND ONE OF THEM IS STILL ATTACHED TO THE POSTERIOR LATERAL NEEDLE TIP. THE REST OF THE NEEDLES WERE NOT RETURNED. THE HANDLE WAS DEPLOYED AND THE REMAINING NEEDLE PRESENTED AT THE HUB. THE NEEDLE SLOTS AND SUTURE PORTS APPEARED NORMAL. INTERNAL INSPECTION FOUND THAT THERE WAS NO BENT SET ON THE HOLDER SHAFT. THERE WAS A NEEDLE STRIKE MARK ON THE BARREL FACE AND THIS CONFIRMED THE REPORTED EXPERIENCE; THE NEEDLE WILL NOT PRESENT AT THE HUB AND WILL JUST BEND UNDER THE BARREL. THE EVIDENCE OF NEEDLE STRIKE MARK ON THE BARREL SUGGESTED THAT THE NEEDLE MIGHT HAVE BEEN DEFLECTED BY AN UNIDENTIFIED CAUSE. DEPLOYING THE DEVICE AT AN ANGLE GREATER THAN 45 DEGREES, OR THE PATIENT ANATOMICAL CONDITION SUCH AS OBESITY, CALCIFICATION OR SCARRING OF THE SITE USE IN DEPLOYING THE DEVICE CAN DEFLECT THE NEEDLES. IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT FEMORAL VEIN. THE INSTRUCTIONS FOR USE (IFU) UNDER DEVICE DESCRIPTION: THE PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL (PROSTAR XL PVS) DEVICE IS DESIGNED TO DELIVER POLYESTER SUTURE(S) TO CLOSE FEMORAL ARTERY PUNCTURE SITES FOLLOWING CATHETERIZATION PROCEDURES. THE PROBABLE CAUSE FOR THE NEEDLE STRIKE MARK ON THE BARREL FACE IS RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. IN ADDITION, A QUERY OF THE COMPLAINT DATABASE WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS WITHIN THIS LOT FOR THE REPORTED DEVICE CODE AND ACTUAL FAILURE MODE AT THE TIME THIS INVESTIGATION WAS PERFORMED. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE PROSTAR XL DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT FEMORAL VEIN AFTER A PROSTHETIC PULMONARY VALVE IMPLANTATION PROCEDURE. REPORTEDLY, THE DEVICE WAS INSERTED WITHOUT INCIDENT, THE RING WAS PULLED WITHOUT RESISTANCE BUT ONLY 3 NEEDLES APPEARED. NEEDLE BACK-DOWN WAS PERFORMED WITHOUT RESISTANCE AND THE RING WAS PULLED A SECOND TIME WITH THE SAME RESULT. SOME EFFORT WAS USED TO REMOVE THE DEVICE FROM THE PATIENT AND SECOND PROSTAR WAS THEN PUT IN AS PER USUAL. THE SUTURES FROM THE FIRST DEVICE REMAINED IN SITU AND WERE LEFT TO TIE AT END OF THE CASE. HEMOSTASIS WAS ACHIEVED AT THE END OF THE CASE WITH TOTAL OF 4 SUTURES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. 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 930136H

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention 22 FR, HEPARIN 3000 UNITS