BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3241573 · Received July 22, 2013

    Report

    Report Number
    2024168-2013-04601
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 29, 2013
    Report Date
    June 29, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER PERCLOSE PROGLIDE DEVICE, REFERENCED WAS FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE WAS DISCARDED AND IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE, ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY (RCFA) WAS ATTEMPTED USING PERCLOSE PROGLIDE DEVICES. REPORTEDLY, DURING INITIAL CANNULATION OF THE VESSEL THE ANTERIOR WALL WAS PUNCTURED AT APPROXIMATELY 45-DEGREE ANGLE WITHOUT DIFFICULTY. THE 0.035-INCH NON-ABBOTT GUIDE WAS WIPED DOWN TO ENSURE NO DRIED BLOOD WAS PRESENT; HOWEVER, AS THE DEVICE WAS ADVANCED ON THE GUIDE WIRE RESISTANCE WAS FELT AND THE DEVICE COULD NOT BE ADVANCED INTO THE LUMEN OF THE VESSEL. THE DEVICE WAS REMOVED OVER THE GUIDE WIRE WITHOUT DIFFICULTY AND RE-POSITIONED, BUT RESISTANCE WAS FELT ONCE AGAIN AND THE DEVICE COULD NOT BE ADVANCED INTO THE VESSEL. A SKIN INCISION OF THE SUBCUTANEOUS TISSUE TRACT WAS MADE AND ANOTHER ATTEMPT WAS MADE TO ADVANCE THE DEVICE INTO THE LUMEN OF THE VESSEL, BUT ONCE AGAIN RESISTANCE WAS MET, THE DEVICE COULD NOT BE ADVANCED INTO THE VESSEL, AND WHEN THE DEVICE WAS REMOVED THE DISTAL GUIDE WAS BENT BACK. A SECOND PROGLIDE DEVICE WAS ATTEMPTED, BUT WITH THE SAME RESULTS; RESISTANCE WAS FELT, THE DEVICE COULD NOT BE ADVANCED INTO THE LUMEN OF THE VESSEL, AND WHEN THE DEVICE WAS REMOVED THE DISTAL GUIDE WAS BENT BACK. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. MILD BRUISING WAS REPORTEDLY PRESENT AT THE ACCESS SITE. DURING THE PROCEDURE A VENOUS SHEATH WAS NOT PRESENT NEXT TO THE ARTERIAL SHEATH. THERE WAS NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE OPERATOR IS IN-TRAINING IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340693 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30325K1

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention SHEATH: 6-FRENCH GUIDE WIRE: 0.035 HEPARIN