BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2182662 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05355
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 7, 2011
    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)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE OTHER PROSTAR XL DEVICE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. 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 SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND THAT THE HANDLE AND 3 NEEDLES WERE IN BACKDOWN POSITION. PRESENCE OF SUTURE SLACK AT THE GUIDE AREA AND THE SUTURE BIGHTS WERE STILL INSIDE THE COILED SUTURE LUMENS. THE POSTERIOR MEDIAL NEEDLE FAILED TO BACK-DOWN AND WAS STILL DEPLOYED AT THE BARREL FACE. THERE WAS MINOR DEFORMATION ON THE SHEATH JUST DISTAL TO HOLDER STOP RING DUE TO THE POSTERIOR MEDIAL NEEDLE THAT WAS DISPLACED AND FOLDED/BENT INSIDE THE SHEATH WHEN THE HANDLE WAS BACKED-DOWN. THERE WERE CLAMP MARKS FOUND ON THE SUTURE AND MARKER TUBES. THERE WERE NEEDLE STRIKE MARKS ON THE BARREL FACE. DURING THE INVESTIGATION, THE HANDLE WAS UNABLE TO DEPLOY BECAUSE OF THE POSTERIOR MEDIAL NEEDLE THAT WAS DISPLACED INSIDE THE SHEATH. THE EVIDENCE OF THE NEEDLE STRIKE MARK ON THE BARREL FACE SUGGESTED THAT THE NEEDLE MIGHT HAVE BEEN DEFLECTED BY AN UNIDENTIFIED CAUSE. 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 FOR DEPLOYING THE DEVICE, CAN DEFLECT THE NEEDLES. REPORTEDLY, THERE WAS MILD CALCIFICATION OF THE RIGHT COMMON FEMORAL ARTERY, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. AS PER THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH COMMON FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE. THE NEEDLE DEPLOYMENT OF EVERY DEVICE IS CHECK DURING THE MANUFACTURING PROCESS TO ENSURE THE NEEDLES/SUTURES ARE IN THE CORRECT ORIENTATION; THEREFORE, THE PROBABLE CAUSE FOR THE NEEDLE STRIKE MARK ON THE BARREL FACE AND FOR THE NEEDLE MISSING/NOT PRESENTED AT THE HUB DURING NEEDLE DEPLOYMENT IS RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. THE CLAMP MARKS FOUND ON THE SUTURE AND MARKER TUBES COULD HAVE BEEN CAUSED WHEN THE OPERATOR CLAMPED THE MARKER TUBE TO STOP THE BLOOD FLOW. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING THE MANUFACTURING PROCESS AND A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF THE MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PRECLOSE TECHNIQUE BEFORE AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. REPORTEDLY, DURING NEEDLE DEPLOYMENT, THE NEEDLES COULD NOT BE PULLED BACK INTO THE DEVICE. ANOTHER PROSTAR XL WAS USED WITH THE SAME RESULTS. THE DEVICE WAS REMOVED AND A SHEATH WAS INSERTED. AFTER THE AAA PROCEDURE, A CUT DOWN WAS PERFORMED AND HEMOSTASIS WAS ACHIEVED. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE 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 030236H

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention HEPARIN