BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2140962 · Received June 27, 2011

    Report

    Report Number
    2024168-2011-04486
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND THE HANDLE WAS IN BACKDOWN POSITION. THERE WERE CLAMP MARKS FOUND ON THE COILED SUTURE LUMENS AND MARKER TUBE. THE NEEDLES WERE NOT RETURNED. THERE WAS NO NEEDLE STRIKE MARK ON THE BARREL FACE. BASED ON THE INVESTIGATION FINDINGS, THE CLAMP MARKS FOUND ON THE COILED SUTURE LUMEN AND THE COLLAPSED SUTURE TUBE AT THE HUB AREA IS AN INDICATION THAT A HEMOSTAT WAS APPLIED BEFORE THE NEEDLE DEPLOYMENT. THIS CONFIRMED THE REPORTED EXPERIENCE OF FAILURE TO DEPLOY NEEDLES. CLAMPING THE SUTURE TUBE INTERFERED WITH SUTURE DEPLOYMENT AND NEEDLE TRAJECTORY CAUSING THE NEEDLE TO BEND AND STRIKE THE BARREL FACE. THE PROSTAR INSTRUCTIONS FOR USE (IFU) STATES: DO NOT CLAMP THE SUTURE LUMEN WITH A HEMOSTAT OR OTHER INSTRUMENT. DOING SO WILL PREVENT THE SUTURE DEPLOYMENT. IT WAS ALSO REPORTED THAT THE PHYSICIAN HAS NOT BEEN TRAINED DIRECTLY BY AN ABBOTT VASCULAR REPRESENTATIVE. THE IFU STATES: THIS DEVICE SHOULD ONLY BE USED BY PHYSICIANS (OR ALLIED HEALTHCARE PROFESSIONALS, AUTHORIZED BY, OR UNDER THE DIRECTION OF, SUCH PHYSICIANS) WHO ARE TRAINED IN DIAGNOSTIC AND THERAPEUTIC CATHETERIZATION PROCEDURES AND WHO HAVE BEEN TRAINED BY AN AUTHORIZED REPRESENTATIVE OF ABBOTT VASCULAR. PRIOR TO USE, THE OPERATOR MUST REVIEW THE INSTRUCTIONS FOR USE AND BE FAMILIAR WITH THE DEPLOYMENT TECHNIQUES ASSOCIATED WITH THE USE OF THIS DEVICE. THERE WERE NO ABNORMAL OBSERVATIONS WITH THE CONDITION OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE CAUSE FOR THIS EVENT IS DUE TO USER ERROR. 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-HANDLING DATABASE WAS PERFORMED AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    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. THE OTHER PROSTAR XL DEVICES ARE BEING SUBMITTED ON SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL USING THE PRE-CLOSE TECHNIQUE WITH A 10FR SHEATH PRIOR TO AN INTERVENTIONAL PROCEDURE (PERCUTANEOUS VALVE IMPLANT). THE PHYSICIAN THEN UPSIZED TO AN 18FR PROCEDURAL SHEATH TO COMPLETE THE INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN ROTATING THE HANDLE TO DEPLOY THE NEEDLES, RESISTANCE WAS FELT. THE NEEDLES WERE FOUND TO BE PARTIALLY DEPLOYED. THE BACKDOWN TECHNIQUE WAS USED AND THE DEVICE WAS REMOVED. A SECOND AND THIRD PROSTAR XL DEVICE WERE USED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING A FOURTH PROSTAR XL DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. REPORTEDLY, THE PHYSICIAN HAS NOT BEEN TRAINED DIRECTLY BY AN ABBOTT VASCULAR REPRESENTATIVE. 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 030366H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 10 AND 18FR