BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2211247 · Received August 15, 2011

    Report

    Report Number
    2024168-2011-05730
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND IT WAS FULLY CLIP DEPLOYED. ALL EXTERNAL AND INTERNAL COMPONENTS WERE IN THEIR APPROPRIATE POST CLIP-DEPLOYED POSITIONS, WITH NO DETECTED ABNORMAL OBSERVATIONS. THE REPORTED FAILURE TO FIRE THE CLIP OFF THE DEVICE WHEN DEPRESSING THE DEPLOYMENT BUTTON CAN BE INFLUENCED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING DEFICIENCIES AND INCORRECT DEPLOYMENT TECHNIQUES. BECAUSE THE CLIP RESIDED ON THE CARRIER TUBE WITHIN THE DELIVERY TUBESET INSIDE THE DEVICE, THERE WOULD NOT BE ANY INTERACTION BETWEEN THE CLIP AND HUMAN TISSUE DURING THE CLIP-FIRING PROCESS WHICH COULD HAVE PREVENTED THE CLIP FROM BEING FIRED OFF THE DELIVERY TUBESET. THERE WAS NO INFORMATION REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE TO SUGGEST THAT THE DEPLOYMENT BUTTON WAS DEPRESSED PRIOR TO COMPLETING THE THUMB ADVANCER STROKE WHICH WOULD HAVE CAUSED THE CLIP-FIRING MECHANISM FROM BEING ACTIVATED TO FIRE THE CLIP DEFICIENCY. BASED ON THE INVESTIGATION FINDINGS, THE REPORTED PRODUCT EXPERIENCE COULD NOT BE CONFIRMED AND A PROBABLE CAUSE COULD NOT BE IDENTIFIED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A REVIEW OF THE COMPLAINT DATABASE FOR THIS LOT DID NOT REVEAL ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT.

    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. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE DEPLOYMENT BUTTON WAS DEPRESSED AND THE CLIP WAS DEPLOYED IT REMAINED ON THE DELIVERY TUBE. THE DEVICE WAS REMOVED AND MANUAL COMPRESSION WAS APPLIED FOR TWENTY MINUTES TO ACHIEVE HEMOSTASIS. ONCE OUTSIDE THE PATIENT ANATOMY, THE DEPLOYMENT BUTTON WAS DEPRESSED AND THE CLIP CAME OFF OF THE DELIVERY TUBE. THE LOCATION OF THE CLIP IS UNKNOWN. A 6FR SHEATH WAS USED DURING INSERTION OF THE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 050176H

    Patients

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