BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2000538 · Received February 24, 2011

    Report

    Report Number
    2024168-2011-01125
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    December 30, 2010
    Report Date
    February 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THAT IT WAS FULLY DEPLOYED WITH ALL THE EXTERNAL COMPONENTS IN CORRECT POST DEPLOYED POSITIONS. THE EXCHANGE SHEATH WAS COMPLETELY SLIT BUT HAD ALSO BEEN STRETCHED BEYOND THE DISTAL END OF THE TUBE SET DURING THUMB ADVANCEMENT INTERFERING WITH CLIP DEPLOYMENT, AS EVIDENCED BY THE TIP BEING RUFFLED FROM STRIKING THE OPENED VESSEL LOCATOR WINGS AND THE CLIP TINES PUNCTURING THE SHEATH DURING DEPLOYMENT; HOWEVER, THE EXCHANGE SHEATH HAD RECOILED WITHIN SPECIFICATIONS WHEN RECEIVED. A POSSIBLE CAUSE FOR THE EXCHANGE SHEATH STRETCHING IS A TIGHT TISSUE TRACT. INSTEAD OF THE TUBE SET SLIDING EASILY WITHIN THE SHEATH, TISSUE COMPRESSION FORCES MAY CAUSE THE SHEATH TO DRAG ALONG WITH THE TUBE SET AS IT IS DISTALLY ADVANCED. SUBSEQUENTLY, THE SHEATH ELONGATES WHICH CAN CAUSE INTERFERENCE WITH CLIP DEPLOYMENT. IT WAS REPORTED THAT THE CATH LAB STAFF CONSIDERED THE PATIENT TO BE MORBIDLY OBESE. PER THE IFU, IT STATES UNDER THE SPECIAL PATIENT POPULATIONS SECTION, THE SAFETY AND EFFECTIVENESS THE STARCLOSE VASCULAR CLOSURE SYSTEM HAVE NOT BEEN ESTABLISHED, IN PATIENT POPULATIONS: PATIENTS WHO ARE MORBIDLY OBESE (BODY MASS INDEX 35 KG/M2). THE VESSEL LOCATOR WINGS WERE ALSO BENT. THE MOST PROBABLE ROOT CAUSE FOR THE BENT VESSEL LOCATOR WINGS IS TISSUE COMPRESSION BETWEEN THE DISTAL END OF THE TUBE SET AND THE VESSEL LOCATOR WINGS DURING THUMB ADVANCEMENT. THE WINGS WILL NOT BE ABLE TO COLLAPSE AND THE DEVICE WILL BE STUCK AND DIFFICULT TO REMOVE; THEREFORE, FORCING THE DEVICE OUT WHICH WOULD BREAK OR BEND THE WINGS. THESE FINDINGS ARE CONSISTENT WITH AND CONFIRM THE REPORTED EXPERIENCE OF DIFFICULT TO DEPLOY THUMB ADVANCER. BASED ON THE INVESTIGATION FINDINGS, THE MOST PROBABLE ROOT CAUSE FOR THE STRETCHED SHEATH AND THE BENT VESSEL LOCATOR WINGS IS RELATED TO OPERATIONAL CONTEXT IN THE USE OF THE DEVICE. NO MANUFACTURING OR QUALITY INSPECTION ISSUES WERE DETECTED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH 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 WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. PATIENT SELECTION-OBESITY.

    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, DURING THUMB ADVANCER DEPLOYMENT, DIFFICULTY WAS ENCOUNTERED AND THE EXCHANGE SHEATH DID NOT SPLIT COMPLETELY. AN ATTEMPT WAS MADE TO DEPLOY THE CLIP, BUT WAS UNSUCCESSFUL AND BLEEDING CONTINUED. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 930306H

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention