BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3250908 · Received July 29, 2013

    Report

    Report Number
    2024168-2013-04724
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 10, 2013
    Report Date
    July 12, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED LOSS OF ARTERIAL ACCESS DURING DEPLOYMENT WAS CONFIRMED. BASED ON VISUAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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. THE STARCLOSE SE DEVICE WAS REPORTEDLY DEPLOYED IN A MILDLY CALCIFIED COMMON FEMORAL ARTERY. THE STARCLOSE SE DEVICE INSTRUCTIONS FOR USE (IFU) STATES UNDER PRECAUTIONS SECTION THAT THE SAFETY AND EFFECTIVENESS OF THE STARCLOSE SE VASCULAR CLOSURE SYSTEM HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM, WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. THE IFU ALSO STATES DO NOT DEPLOY THE CLIP IN AREAS OF CALCIFIED PLAQUE. THE STARCLOSE SE DEVICE WAS REPORTEDLY USED IN A 7-FRENCH SIZED ACCESS SITE. THE IFU STATES UNDER INDICATIONS FOR USE THAT THE STARCLOSE VASCULAR CLOSURE SYSTEM IS INDICATED FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS, AMBULATION, AND DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). THE STARCLOSE SE DEVICE WAS REPORTEDLY DEPLOYED IN A MILDLY CALCIFIED COMMON FEMORAL ARTERY. THE STARCLOSE SE DEVICE INSTRUCTIONS FOR USE (IFU) STATES UNDER PRECAUTIONS SECTION THAT THE SAFETY AND EFFECTIVENESS OF THE STARCLOSE SE VASCULAR CLOSURE SYSTEM HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM, WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. ADDITIONALLY, THE IFU STATES DO NOT DEPLOY THE CLIP IN AREAS OF CALCIFIED PLAQUE. (B)(4). THE DEVICE WAS REPORTEDLY USED IN A 7-FRENCH SIZED ACCESS SITE. THE IFU STATES UNDER INDICATIONS FOR USE THAT THE STARCLOSE VASCULAR CLOSURE SYSTEM IS INDICATED FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS, AMBULATION, AND DISCHARGABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN INTERVENTIONAL PERIPHERAL PROCEDURE, ARTERIOTOMY CLOSURE OF A MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE. REPORTEDLY, NEAR COMPLETION OF THUMB ADVANCER DEPLOYMENT, THE DEVICE CAME COMPLETELY OUT OF THE VESSEL LOSING VESSEL ACCESS, WITH THE LOCATOR WINGS REMAINING DEPLOYED. THE OPERATOR REPORTEDLY DID NOT ENCOUNTER ANY RESISTANCE AND THE DEVICE WAS NOT PULLED BACK WITH EXCESS FORCE. MANUAL ARTERIAL COMPRESSION AND A NON-ABBOTT MECHANICAL CLOSURE DEVICE WERE USED TO ACHIEVE HEMOSTASIS, WHICH CAUSED A REPORTEDLY TWENTY MINUTES DELAY IN THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THE PHYSICIAN WAS 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
    352407 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 30111K2

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention SHEATH: 7-FRENCH, HEPARIN