BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2200093 · Received August 10, 2011

    Report

    Report Number
    2024168-2011-05662
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND IT WAS FULLY CLIP-DEPLOYED. INSPECTION INDICATED THAT THE SHEATH WAS STRETCHED DURING THUMB ADVANCER DEPLOYMENT. SUBSEQUENTLY, AS THE TRIGGER BUTTON WAS DEPRESSED TO FIRE THE CLIP, THE CLIP TINES PUNCTURED INTO THE SHEATH, RESULTING IN THE CLIP BEING CAPTURED AT THE DISTAL END OF THE SHEATH INSTEAD OF DELIVERED TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL AS INTENDED. THE CLIP CAUGHT AT THE DISTAL END OF STRETCHED SHEATH COULD APPEAR VERY SIMILAR TO THE REPORTED PARTIALLY SPLIT SHEATH; HOWEVER, THE SHEATH WAS RETURNED FULLY SLIT. INSPECTION ALSO REVEALED BENT VESSEL LOCATOR WINGS. THE BENT WINGS PREVENTED THEM FROM COLLAPSING INTO THE DELIVERY TUBESET WHEN THE CLIP WAS FIRED. THE BENT WINGS COMBINED WITH STRETCHED SHEATH THAT CAPTURED THE CLIP COULD RESULT IN DIFFICULT DEVICE REMOVAL; HOWEVER, THIS WAS NOT REPORTED. POTENTIAL CONTRIBUTING FACTORS FOR BENT WINGS AND STRETCHED SHEATH INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND INCORRECT DEPLOYMENT TECHNIQUES. RECEIVING INSPECTION RECORDS FOR THE EXCHANGE SHEATH COMPONENT, REVEALED NO MANUFACTURING-RELATED DEFICIENCIES. THE REPORTED CALCIFICATION PRESENT INSIDE THE ARTERY COULD HAVE CONTRIBUTED TO BENT WINGS AND STRETCHED SHEATH. THERE WAS NO INFORMATION REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE TO SUGGEST INADEQUATE NICK-N-SPREAD INCISION WHICH COULD HAVE CONTRIBUTED TO THE DETECTED FAILURE MODES. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR 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 WHEN THE CLIP WAS FIRED. THE PROBABLE CAUSE FOR STRETCHED SHEATH THAT CAPTURED THE CLIP IS TIGHT TISSUE TRACT. INSTEAD OF THE TUBESET SLIDING EASILY WITHIN THE SHEATH WHILE ADVANCING THE THUMB ADVANCER, TISSUE COMPRESSION FORCES MAY CAUSE THE SHEATH TO DRAG ALONG WITH THE TUBESET AS IT IS DISTALLY ADVANCED, RESULTING IN THE SHEATH BEING ELONGATED. THIS IS CONSISTENT WITH THE REPORTED CALCIFICATION IN THE COMMON FEMORAL ARTERY. DAMAGED LOCATOR WINGS AND STRETCHED SHEATH CAN INTERFERE WITH THE CLIP PLACEMENT AS REPORTED AND OBSERVED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A REVIEW OF THE COMPLAINT DATABASE FOR THIS LOT REVEALED NO 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 A MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED AFTER A DIAGNOSTIC PROCEDURE USING A STARCLOSE SE DEVICE. REPORTEDLY, THE SHEATH PARTIALLY SPLIT; HOWEVER, THE CLIP DID DEPLOY BUT FAILED TO ACHIEVE HEMOSTASIS. MANUAL ARTERIAL COMPRESSION WAS USED TO ACHIEVED HEMOSTASIS. 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 STARCLOSE SE 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 89 YR Required Intervention SHEATH: 6F