BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 4811796 · Received June 2, 2015

    Report

    Report Number
    2024168-2015-03100
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    May 11, 2015
    Report Date
    May 11, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. PATIENT SELECTION: THE STARCLOSE SE DEVICE WAS DEPLOYED IN A MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY. PER THE INSTRUCTIONS FOR USE - DO NOT DEPLOY THE CLIP IN AREAS OF CALCIFIED PLAQUE. AGAINST RESISTANCE: PER THE INSTRUCTIONS FOR USE, DO NOT ADVANCE OR WITHDRAW THE PERCLOSE PROGLIDE DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THAT RESISTANCE HAS BEEN DETERMINED. EXCESSIVE FORCE USED TO ADVANCE OR TORQUE THE PERCLOSE PROGLIDE SMC DEVICE SHOULD BE AVOIDED, AS THIS MAY LEAD TO SIGNIFICANT VESSEL DAMAGE AND/OR BREAKAGE OF THE DEVICE, WHICH MAY NECESSITATE INTERVENTION AND/OR SURGICAL REMOVAL OF THE DEVICE AND VESSEL REPAIR. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND THE REPORTED EVENT OF RESISTANCE DURING INSERTION, DIFFICULTY TO REMOVE AND FAILURE TO ACHIEVE HEMOSTASIS WERE CONFIRMED. THE REPORTED RETRACTION PROBLEM AND USING THE SAFETY RELEASE MECHANISMS COULD NOT BE CONFIRMED AS THE DEVICE WAS RETURNED WITH THE THUMB ADVANCER STILL FULLY ADVANCED, WHICH INDICATES THE ACCESS PORTS WERE NOT USED. THE REPORTED EVENT OF RESISTANCE DURING INSERTION, DIFFICULTY TO REMOVE AND FAILURE TO ACHIEVE HEMOSTASIS APPEARS TO BE RELATED TO USE AND INTERACTION OF THE DEVICE WITH THE HEAVY CALCIFICATION AT THE ACCESS SITE. THE REPORTED RETRACTION PROBLEM AND USING THE SAFETY RELEASE MECHANISMS APPEARS TO BE RELATED TO USE ERROR SUCH THAT THE ACCESS PORTS WERE NOT USED. THE TREATMENT APPEARS TO BE RELATED TO PROCEDURAL CIRCUMSTANCE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. REPORTEDLY, THE DEVICE WAS USED IN A CALCIFIED ACCESS SITE. THE PROGLIDE INSTRUCTIONS FOR USE (IFU) STATES: DO NOT DEPLOY THE CLIP IN AREAS OF CALCIFIED PLAQUE. REPORTEDLY, THE DEVICE WAS USED AGAINST RESISTANCE. THE IFU STATES: DO NOT ADVANCE OR WITHDRAW THE STARCLOSE VASCULAR CLOSURE DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THAT RESISTANCE HAS BEEN DETERMINED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE SCARRED AND HEAVILY CALCIFIED LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE DEVICE WITH A 5F SHEATH AFTER A DIAGNOSTIC ILIAC ANGIOPLASTY PROCEDURE. REPORTEDLY, THERE WAS MINOR RESISTANCE WITH SHEATH INSERTION DUE TO THE SCARRED ACCESS SITE AND AFTER CLIP DEPLOYMENT THE DEVICE COULD NOT BE WITHDRAWN FROM THE PATIENT. THE SAFETY RELEASE MECHANISM WAS ACTIVATED TO FACILITATE DEVICE REMOVAL, HOWEVER, THE DEVICE STILL COULD NOT BE REMOVED FROM THE PATIENT ANATOMY. THE DEVICE WAS FIRMLY PULLED AND THE DEVICE WAS REMOVED. HEMOSTASIS WAS ACHIEVED WITH THE STARCLOSE CLIP AND 20 MINUTES OF APPLIED MANUAL ARTERIAL COMPRESSION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE STARCLOSE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356759 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 41021K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 5F, HEPARIN