BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1982016 · Received February 8, 2011

    Report

    Report Number
    2024168-2011-00770
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. PATIENT OBESITY.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE REVEALED IT HAD BEEN PARTIALLY DEPLOYED. THE CONDITION OF THE DEVICE WAS CONSISTENT WITH THE SAFETY RELEASE HAVING BEEN ACTIVATED WITH BOTH THE PLUNGER AND LOCATOR WINGS RETRACTED. DURING AN ATTEMPT TO DEPLOY THE DEVICE, ALL DEPLOYMENT FUNCTIONS SUCCESSFULLY OPERATED AS DESIGNED WITH NO DETECTED RESISTANCE TO PLUNGER AND THUMB ADVANCER DEPLOYMENT. ADDITIONALLY, EXTERNAL AND INTERNAL EXAMINATION OF THE DEVICE DID NOT DETECT ANY DAMAGE OR ANOMALY THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO OTHER OBSERVATIONS WERE NOTED. THE DEVICE PERFORMED ACCORDING TO SPECIFICATION. THE REPORTED USE OF THE DEVICE IN AN OBESE PATIENT IS INCONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU) AND LIKELY PLAYED A SIGNIFICANT ROLE IN THE REPORTED EVENT. PER THE IFU, UNDER SPECIAL PATIENT POPULATIONS, THE SAFETY AND EFFECTIVENESS OF THE STARCLOSE VASCULAR CLOSURE SYSTEM HAVE NOT BEEN ESTABLISHED IN PATIENT POPULATIONS WHO ARE MORBIDLY OBESE WITH A BODY MASS INDEX GREATER THAN 5 KG/M2. A QUERY OF THE COMPLAINT-HANDLING DATABASE PERFORMED DID NOT REVEAL ANY OTHER REPORTED CASES OF DIFFICULTY DEPLOYING THE PLUNGER AND THUMB ADVANCER WITH THE SAME LOT NUMBER OF THIS STARCLOSE SE DEVICE. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE REPORTED EVENT IS RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, ALTHOUGH DURING PLUNGER DEPLOYMENT RESISTANCE WAS FELT, PLUNGER DEPLOYMENT WAS COMPLETED. HOWEVER, DURING STEP #3, THE THUMB ADVANCER COULD NOT BE DISTALLY ADVANCED. THE SAFETY RELEASE WAS ACTIVATED, WHICH RETRACTED THE LOCATOR WINGS AND RELEASED THE DEVICE FROM THE VESSEL. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, 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 940246H

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention