BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2193319 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05558
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND IT WAS PARTIALLY DEPLOYED IN THE SAFETY RELEASE ACTIVATED STATE WITH THE PLUNGER AND VESSEL LOCATOR WINGS (VLW) RETRACTED. THE THUMB ADVANCER/DELIVERY TUBESET HAD BEEN PARTIALLY DEPLOYED FROM THE INITIAL PLUNGER DEPLOYMENT PRIOR TO SAFETY RELEASE ACTIVATION, WITH SUBSEQUENT INITIAL/PARTIAL SHEATH SPLITTING. THERE WAS NO DETECTED EXTERNAL DAMAGE OR ANOMALY. INTERNAL INSPECTION CONFIRMED NO ANOMALY. DURING TESTING, THE DEVICE WAS RESET FOR REDEPLOYMENT AND THE TEST WAS SUCCESSFUL WITH COMPLETE THUMB ADVANCER/DELIVERY TUBE DEPLOYMENT ACCOMPANIED BY FULL SHEATH SPLITTING. NO ANOMALY WAS DETECTED DURING THE TEST. A POSSIBLE CAUSE FOR THE INABILITY TO SPLIT THE SHEATH MAY BE RELATED TO A TIGHT TISSUE TRACT, INADEQUATE NICK AND SPREAD INCISION AND/OR ANATOMICAL ISSUES, WHICH CREATED HIGHER THAN NORMAL RESISTANCE TO THUMB ADVANCER/DELIVERY TUBE DEPLOYMENT THROUGH THE TISSUE TRACT. THE TIGHT TISSUE TRACT MAY ALSO CONSTRAIN THE SHEATH FROM SPLITTING CORRECTLY DURING THE DELIVERY TUBE DEPLOYMENT THROUGH THE SHEATH. . BASED ON THIS INVESTIGATION THERE IS NO DETECTED LOT SPECIFIC PRODUCT QUALITY DEFICIENCY AND THE LIKELY CAUSE FOR THE REPORTED EVENT IS RELATED TO THE OPERATIONAL CONTEXT OF THE DEVICE. 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 WAS NO DETECTED MANUFACTURING OR QUALITY DEFICIENCY. TO ASSURE ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATION, A SAMPLE FROM THE LOT IS FUNCTIONALLY AND DESTRUCTIVELY TESTED TO ASSURE PROPER DEVICE OPERATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT YET BEEN RETURNED. 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 THE STARCLOSE SE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE SHEATH DID NOT SPLIT COMPLETELY. MANUAL ARTERIAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 050176H

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention SHEATH: 6FOTHER: ANGIOMAX