BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2122160 · Received June 13, 2011

    Report

    Report Number
    2024168-2011-04139
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION FOUND THE DEVICE WAS RETURNED FULLY CLIP-DEPLOYED WITH ALL COMPONENTS IN APPROPRIATE POST CLIP-DEPLOYMENT POSITION. THE CLIP-FIRING MECHANISM WAS ACTIVATED AND THERE WERE CLIP TINES MARKS ON CARRIER TUBE, INDICATING THAT THE CLIP WAS LOADED ONTO THE CARRIER TUBE DURING MANUFACTURING AND DEPLOYED DURING USE. ALSO, THE VESSEL LOCATOR WINGS WERE FULLY COLLAPSED AND THE SHEATH FULLY SLIT. THERE WERE NO ABNORMAL OBSERVATIONS THAT COULD PREVENT THE CLIP FROM BEING FIRED AND DELIVERED TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL. BASED ON THE INVESTIGATION FINDINGS, THE REPORTED EXPERIENCE COULD NOT BE CONFIRMED AND A CAUSE RELATED TO THE DEVICE COULD NOT BE DETERMINED. CONTRIBUTING FACTORS FOR THE REPORTED PRODUCT EXPERIENCE INCLUDED, BUT NOT LIMITED TO, MANUFACTURING DEFICIENCIES; HOWEVER, THE RETURNED CONDITION OF THE DEVICE INDICATED THAT IT WAS PROPERLY DEPLOYED TO FIRE THE CLIP OFF THE DEVICE DURING USE AS DESIGNED. ALSO, EVERY CLIP IS PROPERLY LOADED ONTO THE CARRIER TUBE DURING MANUFACTURING. ANATOMICAL CONDITIONS; HOWEVER, CONSISTENT WITH THE REPORTED INFORMATION, A FEMORAL ANGIOGRAM WAS TAKEN AND THERE WAS NO ARTERIAL CALCIFICATION PRESENT. DEPLOYMENT TECHNIQUE; HOWEVER THERE WAS NO INFORMATION REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE THAT SUGGEST INCORRECT TECHNIQUE. ALSO, THE RETURNED CONDITION REVEALED A PROPERLY DEPLOYED DEVICE. THE PATIENTS BODILY MOVEMENTS DURING THE PROCEDURE COULD RESULT IN THE CLIP BEING OFF-TARGETED WHEN FIRED, RESULTING IN A FAILURE TO ACHIEVE HEMOSTASIS. WHEN FIRING THE CLIP IT COULD APPEAR VERY SIMILAR TO THE REPORTED CLIP DID NOT DEPLOY; HOWEVER, THIS COULD NOT BE CONFIRMED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. 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 REVEALED NO OTHER INCIDENTS WHERE THE CLIP DID NOT DEPLOY. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT BASED ON ACTUAL INVESTIGATION FINDINGS REVEALED NO OTHER INCIDENTS THAT EXHIBITED AN UNCONFIRMED REPORTED PRODUCT EXPERIENCE WITH NO KNOWN DEVICE PROBLEM DETECTED. 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 TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE CLIP DID NOT DEPLOY. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 19 YR Required Intervention