BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2143759 · Received June 29, 2011

    Report

    Report Number
    2024168-2011-04561
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. ESTIMATED DATE OF EVENT (REPORTED AS OCCURRING LAST WEEK). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND THAT IT WAS FULLY CLIP-DEPLOYED AND THE RETURNED CONDITION SUBSTANTIATED THE REPORTED PRODUCT EXPERIENCE. INSPECTION OF THE DEVICE SUGGESTED THAT THE LOCATOR WINGS WERE INITIALLY BENT DURING THE THUMB ADVANCER DEPLOYMENT DUE TO TISSUE COMPACTION THAT EXERTED A DISTAL FORCE ON THE WINGS PREVENTING THE WINGS FROM FULLY COLLAPSING INTO THE DELIVERY TUBESET WHEN THE CLIP WAS FIRED. THE FAILURE OF THE WINGS TO COMPLETELY COLLAPSE INTO THE DELIVERY TUBESET DIRECTLY RESULTED IN DIFFICULT DEVICE REMOVAL AS REPORTED. THE ACCESS PORTS AND SAFETY RELEASE BUTTON WERE UTILIZED TO FACILITATE THE DEVICE REMOVAL AS INSTRUCTED IN THE INSTRUCTIONS FOR USE. THE DEVICE COULD NOT BE RELEASED FROM THE ARTERY DUE TO BENT WINGS THAT PREVENTED THEM FROM COLLAPSING INTO THE TUBESET. WHEN THE DEVICE WAS PULLED FROM THE ANATOMY THE WINGS DETACHED FROM THE DISTAL RETAINING RING; HOWEVER, ALL BROKEN WINGS REMAINED SECURELY ATTACHED WITHIN THE LOCATOR. THE PLUNGER WAS FULLY ENGAGED WHICH IS CONSISTENT WITH POST-PROCEDURE MANIPULATION. CONTRIBUTING FACTORS FOR DAMAGED VESSEL LOCATOR WINGS INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, ANATOMICAL CONDITIONS OR DEPLOYMENT TECHNIQUE. TO ENSURE THIS IS NOT RELATED TO MANUFACTURING, EVERY VESSEL LOCATOR WING IS INSPECTED FOR PROPER ASSEMBLY. THERE WAS NO REPORTED CHALLENGING ANATOMICAL CONDITION OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE THAT SUGGESTED INCORRECT TECHNIQUE. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR THE BENT AND BROKEN LOCATOR WINGS THAT DIRECTLY RESULTED IN THE REPORTED DIFFICULT DEVICE REMOVAL IS TISSUE COMPACTION THAT EXERTED A DISTAL FORCE ON THE WINGS WHILE IN THE TISSUE TRACT. TISSUE TRAPPED BETWEEN THE DISTAL END OF THE TUBESET AND THE LOCATOR WINGS CAN BEND THE WINGS AND EVENTUALLY BREAK THEM DURING FORCEFUL REMOVAL. NO MANUFACTURING OR QUALITY DEFICIENCIES WERE DETECTED. THE PROBABLE CAUSE FOR THE REPORTED DAMAGED LOCATOR WINGS THAT SUBSEQUENTLY RESULTED IN DIFFICULT DEVICE REMOVAL WAS DETERMINED TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE DEVICE AND NOT A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT WAS PERFORMED AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING THE STARCLOSE SE DEVICE AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER THE CLIP WAS DEPLOYED, THE DEVICE COULD NOT BE REMOVED; IT WAS STUCK. AS PER THE INSTRUCTIONS FOR USE, THE ACCESS PORTS AND SAFETY RELEASE FEATURES WERE USED, BUT THE DEVICE DID NOT RELEASE. THE DEVICE WAS PULLED AND REMOVED FROM THE ANATOMY WITH THE USE OF HEMOSTATS. ALTHOUGH THE CLIP ACHIEVED HEMOSTASIS, THE PHYSICIAN DECIDED TO APPLY MANUAL ARTERIAL COMPRESSION FOR 5 MINUTES AS A PRECAUTIONARY MEASURE. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PHYSICIAN WAS REPORTED AS BEING PROFICIENT IN THE USE OF THE DEVICE. 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 030346H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention