BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2851572 · Received November 29, 2012

    Report

    Report Number
    2024168-2012-07559
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    October 25, 2012
    Report Date
    November 12, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT SELECTION, PER INSTRUCTIONS FOR USE, UNDER PRECAUTIONS: DO NOT DEPLOY THE CLIP IN AREAS OF CALCIFIED PLAQUE. ALSO, DO NOT ADVANCE OR WITHDRAW THE STARCLOSE VASCULAR CLOSURE DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THE RESISTANCE HAS BEEN DETERMINED. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED EVENT DESCRIPTION - THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED COMPLAINT WAS CONFIRMED BASED ON THE TORN SHEATH THAT RESULTED IN THE REPORTED EXPERIENCE. BASED ON THE REPORTED INFORMATION, MANUFACTURING INSPECTION CRITERIA AND ANALYSIS OF THE RETURNED DEVICE, PROBABLE CAUSE FOR THE REPORTED EVENT WAS DETERMINED TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM 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). CORRECTION - EXPIRATION DATE WAS CORRECTED FROM 04/30/2012 TO 04/30/2014.

    Description of Event or Problem · 1

    CORRECTION TO THE INITIAL MEDWATCH REPORT: IT WAS INITIALLY REPORTED THAT THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OF 12-15 MINUTES; HOWEVER, ADDITIONAL INFORMATION REVEALED THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE MODERATELY CALCIFIED LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE WITH A 6FR SHEATH, AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN INSERTING THE DEVICE INTO THE INTRODUCER SHEATH AN ABNORMAL RESISTANCE WAS FELT; HOWEVER, THE DEVICE COULD BE INSERTED. WHEN ATTEMPTING TO SPLIT THE SHEATH, IT WAS NOTICED THAT THE SHEATH WAS NOT SPLITTING CORRECTLY, IT WAS CRIMPING AS THE CUTTER OF THE SYSTEM HAD BEEN DISPOSITIONED. THE DEVICE WAS REMOVED AND MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OF 12-15 MINUTES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE STARCLOSE SE 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 20605K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6FR