BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3973392 · Received August 1, 2014

    Report

    Report Number
    2024168-2014-04907
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 11, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: IT WAS INITIALLY REPORTED THAT THE PHYSICIAN WAS TRAINED IN THE USE OF THE PROGLIDE DEVICE; HOWEVER, THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE STARCLOSE SE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED THE SHEATH DID NOT SPLIT AS EXPECTED WAS CONFIRMED. BASED ON A VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO ASSOCIATED NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IT WAS REPORTED THAT A VENOUS SHEATH WAS NEXT TO THE ARTERIAL SHEATH. THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN THE FOLLOWING PATIENT POPULATIONS: PATIENTS WITH IPSILATERAL FEMORAL VENOUS SHEATH DURING THE CATHETERIZATION PROCEDURE. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE WITH A 7FR SHEATH AFTER A CORONARY INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN TRYING TO PUSH DOWN THE CUTTER, IT WAS NOT CUTTING THE SHEATH, BUT PUSHING IT DOWN CAUSING THE SHEATH TO "SMASH DOWN". IT IS UNKNOWN IF THE EXCHANGE SHEATH CONNECTED TO THE CLIP APPLIER. MANUAL ARTERIAL COMPRESSION AND A NON-ABBOTT DEVICE WERE USED TO ACHIEVE HEMOSTASIS. THE PHYSICIAN HAS BEEN TRAINED IN THE USE OF THE PROGLIDE DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT CORRECTED INFORMATION: THE PHYSICIAN WAS REPORTEDLY TRAINED IN THE USE OF THE STARCLOSE SE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450793 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 40317K1

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention SHEATH: 7FR, ANGIOMAX