BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2131912 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04278
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 11, 2011
    Report Date
    May 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WITHOUT THE PRODUCT TO EXAMINE, NO DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE REPORTED INCIDENT. 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 A 100% INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. AS FOR OTHER POSSIBLE CAUSES, THE INFORMATION PROVIDED BY THE CUSTOMER IS LIMITED AND DOES NOT ALLOW FOR ASSIGNING A PROBABLE CAUSE TO THE EXPERIENCED EVENT. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY MANUFACTURING RELATED NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. BASED ON THE INFORMATION PROVIDED, 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. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE PROGLIDE DEVICE IS BEING REPORTED UNDER SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE AND STARCLOSE SE DEVICES ATTEMPTED ARTERIOTOMY CLOSURE A MILDLY CALCIFIED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE ILIAC). THE ACCESS WAS RETROGRADE USING A 7FR INTRODUCER SHEATH. REPORTEDLY, A CUFF MISS OCCURRED USING THE PROGLIDE DEVICE. THE PROGLIDE WAS REMOVED AND A STARCLOSE SE DEVICE WAS USED; HOWEVER, HEMOSTASIS WAS NOT ACHIEVED AFTER DEPLOYING THE CLIP. HEMOSTASIS WAS ACHIEVED USING MANUAL ARTERIAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. 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 010346H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention