BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2192290 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05527
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE DEVICE FOUND THAT THE HANDLE AND NEEDLES WERE RETURNED IN BACKDOWN POSITION. THERE WAS PRESENCE OF SUTURE SLACK AT THE GUIDE AREA AND THE SUTURE BIGHTS WERE STILL INSIDE THE COILED SUTURE LUMENS. THERE WAS NO CLAMP MARK FOUND ON THE COILED SUTURE TUBES. THERE WAS A NEEDLE STRIKE MARK ON THE BARREL FACE, WHICH CONFIRMS THE REPORTED EXPERIENCE OF NEEDLES DID NOT COME THROUGH THE BARREL/DID NOT PRESENT AT THE HUB. THE EVIDENCE OF A NEEDLE STRIKE MARK ON THE BARREL SUGGESTED THAT THE NEEDLE MIGHT HAVE BEEN DEFLECTED BY AN UNIDENTIFIED CAUSE. DURING THE INVESTIGATION, THE HANDLE WAS DEPLOYED AND ALL THE NEEDLES PRESENTED AT THE HUB. DEPLOYING THE DEVICE AT AN ANGLE GREATER THAN 45 DEGREES, OR PATIENT ANATOMICAL CONDITIONS SUCH AS, OBESITY, CALCIFICATION OR SCARRING OF THE SITE USED IN DEPLOYING THE DEVICE CAN DEFLECT THE NEEDLES. THE PROBABLE CAUSE FOR THE NEEDLE STRIKE MARK ON THE BARREL FACE AND FOR THE NEEDLES NOT PRESENTED AT THE HUB DURING NEEDLE DEPLOYMENT IS RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED AND NOT A PRODUCT QUALITY DEFICIENCY. REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR FAILURE TO DEPLOY THE NEEDLES. BASED ON THE INVESTIGATION, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY. TO HELP ENSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING AND A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    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 RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED TO DEPLOY A PROSTAR XL DEVICE IN A NON-CALCIFIED, NON-TORTUOUS COMMON FEMORAL ARTERY (CFA) PRIOR TO AN ENDOVASCULAR AORTIC PROCEDURE (EVAR) IN A PRE-CLOSURE FASHION. REPORTEDLY, WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE NEEDLES THROUGH THE BARREL, NO NEEDLES CAME THROUGH. IT WAS INDICATED THAT NO RESISTANCE WAS FELT AT ANY POINT DURING DEPLOYMENT. THE DEVICE WAS REMOVED FROM THE PATIENT'S GROIN AND ANOTHER PROSTAR XL WAS SUCCESSFULLY USED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS. A 10 FR. SHEATH WAS USED DURING PRE-CLOSURE AND AN 18 FR. SHEATH WAS USED DURING THE INDEX PROCEDURE. THE PHYSICIAN IS TRAINED IN THE USE OF THE PROSTAR XL DEVICE. 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 030306H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 10FR, 18 FR. OTHER: HEPARIN.