BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2132874 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04323
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO PERFORM A THOROUGH ANALYSIS ON THE PRODUCT BECAUSE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. FURTHERMORE, ADEQUATE INFORMATION THAT WOULD MAKE IT POSSIBLE TO ASSIGN A PROBABLE CAUSE TO THIS EVENT WAS NOT PROVIDED. THEREFORE, WITHOUT THE PRODUCT TO EXAMINE, NO DETERMINATION CAN BE MADE AS TO THE CAUSE OF THE REPORTED DISCREPANCY. FAILURE TO ACHIEVE HEMOSTASIS MAY BE DUE TO A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO A MISLODGED/MISLOCATED CLIP (BECAUSE OF INADEQUATE NICK AND SPREAD), BENT/BROKEN DEVICE DUE TO TISSUE COMPACTION, ANATOMICAL CONDITIONS AND MANUFACTURING. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO AN INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY MANUFACTURING RELATED NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. BASED ON THE INFORMATION AVAILABLE, THE INSPECTION CRITERIA AND THE REVIEW OF THE LOT HISTORY RECORD THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN IN TRAINING IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER DEPLOYING THE DEVICE, NO HEMOSTASIS WAS ACHIEVED. MANUAL COMPRESSION WAS APPLIED FOR APPROXIMATELY 8 MINUTES TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 930256H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention