BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1894965 · Received November 5, 2010

    Report

    Report Number
    2953144-2010-02743
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ABBOTT VASCULAR-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. PROSTAR XL DEVICE #1, #2 AND #3, PART# 12322-02, LOT# 900146H, ARE BEING FILED UNDER A SEPARATE MANUFACTURED REPORT NUMBER. PROSTAR XL DEVICE #4 AND #6, PART# 12322-02, LOT# 910346H, ARE BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THE HANDLE WAS IN BACKDOWN POSITION. THERE WERE CLAMP MARKS FOUND ON THE COILED SUTURE LUMEN AND MARKER TUBE. THE NEEDLES WERE NOT RETURNED AND THERE WAS NO NEEDLE STRIKE MARK ON THE FACE OF THE BARREL. THERE WERE TWO GREEN SUTURE TAILS APPROXIMATELY 3-1/4 INCHES THAT WERE EXPOSED AT THE GUIDE. ALTHOUGH IT WAS REPORTED THAT THE SUTURE BROKE, THE EVALUATION OF THE DEVICE FOUND THAT ALL OF THE GREEN SUTURE AND APPROXIMATELY 12 INCHES OF WHITE SUTURE WERE RETURNED WITHOUT A SUTURE BREAK, AS REPORTED. BASED ON THE INVESTIGATION FINDINGS, THE CLAMP MARKS FOUND ON THE COILED SUTURE LUMEN AND THE COLLAPSED SUTURE TUBE IS AN INDICATION THAT A HEMOSTAT WAS APPLIED BEFORE NEEDLE DEPLOYMENT. CLAMPING THE SUTURE TUBE INTERFERED WITH SUTURE DEPLOYMENT AND NEEDLE TRAJECTORY, WHICH CAN CAUSE THE NEEDLE TO BEND AND STRIKE THE FACE OF THE BARREL. THE INSTRUCTIONS FOR USE STATE UNDER DEVICE PLACEMENT AND NEEDLE DEPLOYMENT, DO NOT CLAMP THE SUTURE LUMEN WITH A HEMOSTAT OR OTHER INSTRUMENT. DOING SO WILL PREVENT SUTURE DEPLOYMENT. THERE WERE NO ABNORMAL OBSERVATIONS WITH THE CONDITION OF THE RETURNED DEVICE THAT COULD HAVE CONTRIBUTED TO THE REPORTED EXPERIENCE. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE REPORTED EXPERIENCE IS DUE TO INCORRECT OPERATOR TECHNIQUE. ADDITIONALLY, THE CUSTOMER RETURNED THREE UNUSED REPRESENTATIVE SAMPLE DEVICES RELATED TO THIS PRODUCT EXPERIENCE FOR EVALUATION FROM LOT NUMBERS 900146H AND 910346H. THE DEVICES WERE FUNCTIONALLY TESTED AND THE RESULTS WERE ACCEPTABLE. NO DEVICE MALFUNCTION FOUND. NO MANUFACTURING OR QUALITY ISSUE WAS 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 TRAINED IN THE USE OF THE PROSTAR XL DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT FEMORAL ARTERY USING A PRE-CLOSE TECHNIQUE BEFORE AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING NEEDLE DEPLOYMENT, NONE OF THE NEEDLES RETRACTED. "TWO OF THE NEEDLES STAYED IN OTHER POSITION AND IT WAS IMPOSSIBLE TO RETRACT THE OTHER 2 NEEDLES." THE DEVICE WAS REMOVED AND A SECOND AND THIRD PROSTAR XL DEVICE WERE ATTEMPTED, BUT ALSO RESULTED IN NONE OF THE NEEDLES RETRACTING. THE DEVICE WAS REMOVED AND THREE ADDITIONAL PROSTAR XL DEVICES WERE ATTEMPTED, BUT ALTHOUGH THE NEEDLES RETRACTED WHEN PULLING OUT THE NEEDLES, THE SUTURE BROKE ON ALL THREE DEVICES. HEMOSTASIS WAS ACHIEVED BY TYING THE ONE REMAINING SUTURE INTO A KNOT FROM THE LAST PROSTAR XL INSERTED. AN 8MM PERIPHERAL DILATATION BALLOON WAS INFLATED FROM A CONTRALATERAL APPROACH VIA THE FEMORAL ARTERY FOR TWO MINUTES AND MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. "THE PATIENT WAS OK WITHOUT COMPLICATIONS." THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED RHEUMATOID FACTOR (RF) RESULTS GENERATED BY IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. REPEAT TESTING WITH REAGENT OF DIFFERENT LOT PRODUCED MOSTLY NEGATIVE RESULTS. THERE WAS NO EFFECT TO THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR-REDWOOD CITY NA 910346H

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention DEVICE #4 AND #6, PROSTAR XL: PART # 12322-02| DEVICE #1, #2, AND #3, PROSTAR XL: PART# 12322-02| LOT# 910346H| LOT# 900146H