BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1911179 · Received November 30, 2010

    Report

    Report Number
    2953144-2010-03040
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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.(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND BENT BUT INTACT LOCATOR WINGS AND CONFIRMED THE REPORTED EVENT. A POSSIBLE CAUSE FOR THE WINGS DAMAGED CONDITION MAY HAVE BEEN THE COMPACTION OF TISSUE BETWEEN THE DEPLOYED LOCATOR WINGS AND THE DISTAL END OF THE DEVICES CLIP DELIVERY TUBE BENDING THE WINGS DISTALLY. THIS CONDITION CAN RESULT IN THE INABILITY OF THE LOCATOR WINGS TO RETRACT INTO THE CLIP DELIVERY TUBE AFTER CLIP DEPLOYMENT, REQUIRING THE USE OF THE ACCESS PORT REMOVAL METHOD AS REPORTED TO ASSIST WITH DEVICE REMOVAL. ADDITIONALLY, THE REPORTED 16 PRIOR ARTERIOTOMY PROCEDURES WOULD HAVE GENERATED SCAR TISSUE AND LIKELY PLAY A SIGNIFICANT ROLE WITH THE REPORTED EVENT. THERE WAS NO OTHER DETECTED DAMAGE OR ANOMALY WITH THE DEVICE. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE REPORTED EVENT AND DAMAGED CONDITION OF THE DEVICE IS RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. 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 TECHNICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE STARCLOSE SE WAS DIFFICULT TO REMOVE AFTER THE CLIP WAS DEPLOYED. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, THE ACCESS PORTS WERE USED TO FACILITATE DEVICE REMOVAL. THE CLIP OF THE STARCLOSE SE DEVICE ACHIEVED HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER THE CLIP WAS DEPLOYED, THE DEVICE WAS DIFFICULT TO REMOVE FROM THE PATIENT'S ANATOMY. THE ACCESS PORTS, SAFETY RELEASE BUTTON AND FORCE WERE USED TO REMOVE THE DEVICE FROM THE PATIENT ANATOMY. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THOUGH REQUESTED, 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-REDWOOD CITY 920386H

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention