BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2131119 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04240
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 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 FULLY CLIP-DEPLOYED. INSPECTION OF THE RETURNED DEVICE SUGGESTED THAT THE LOCATOR WINGS WERE BENT DURING THE THUMB ADVANCER DEPLOYMENT, PREVENTING THE WINGS FROM FULLY COLLAPSING INTO THE DELIVERY TUBESET WHEN THE CLIP WAS FIRED. SUBSEQUENTLY, THE CLIP WOULD HAVE CAUGHT WITHIN THE LOCATOR AND LANDED ON THE SKIN SURFACE DURING THE DEVICE REMOVAL. POSSIBLE CONTRIBUTING FACTORS FOR BENT VESSEL LOCATOR WINGS AND SUBSEQUENT MISLOCATED CLIP INCLUDE, BUT ARE NOT LIMITED TO MANUFACTURING, ANATOMICAL CONDITIONS, AND DEPLOYMENT TECHNIQUE. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. EVERY VESSEL LOCATOR WINGS ASSEMBLY WAS PROPERLY ASSEMBLED AND INSPECTED DURING MANUFACTURING. THERE WERE NO CHALLENGING ANATOMICAL CONDITIONS REPORTED. THE REPORTED INADEQUATE NICK-AND-SPREAD COULD CONTRIBUTE TO BENT VESSEL LOCATOR WINGS; HOWEVER, THIS COULD NOT BE CONFIRMED. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR THE BENT LOCATOR WINGS 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 INTERFERE WITH THE CLIP DEPLOYMENT. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT REVEALED NO OTHER INCIDENTS WITH REPORTED MISLOCATED CLIP ON TOP OF THE SKIN SURFACE. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT BASED ON ACTUAL INVESTIGATION FINDINGS REVEALED NO OTHER INCIDENTS THAT EXHIBITED BENT LOCATOR WINGS AS THIS INCIDENT. A REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. OVERALL, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN IN-TRAINING IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A NON-CALCIFIED COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, THE STARCLOSE SE DEVICE WAS REMOVED AND THE CLIP WAS FOUND ON THE SKIN SURFACE. THE CLIP WAS REMOVED FROM THE SKIN SURFACE AND HEMOSTASIS WAS ACHIEVED USING MANUAL ARTERIAL COMPRESSION. REPORTEDLY, THE INCISION CREATED TO ACCOMMODATE THE INSERTION OF THE CLIP WAS NOT ADEQUATE. 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 010346H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention