BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2123957 · Received June 14, 2011

    Report

    Report Number
    2024168-2011-04177
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 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
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND THE DEVICE FULLY CLIP DEPLOYED AND THE THUMB ADVANCER WAS LOCKED. THE EXCHANGE SHEATH WAS COMPLETELY SLIT, BUT HAD CAPTURED THE CLIP DURING DEPLOYMENT. THE BULBOUS SHAPE OF THE DISTAL TIP OF THE SHEATH AND THE CLIP DEPLOYED INTO THE SHEATH INDICATES IT WAS STRETCHED BEYOND THE DISTAL END OF THE EXCHANGE SHEATH DURING THUMB ADVANCEMENT. HOWEVER, THE EXCHANGE SHEATH WAS COMPLETELY SLIT AND HAD RECOILED WITHIN SPECIFICATIONS WHEN RECEIVED. BASED ON THESE FINDINGS, THE REPORT OF THE INCOMPLETE SHEATH SLITTING CANNOT BE CONFIRMED. HOWEVER, DIFFICULTY DURING SHEATH SLITTING WAS INDICATED BY THE DAMAGE DETECTED WITH THE EXCHANGE SHEATH. THE GARAGE LEAVES WERE BENT AND A PORTION OF THE TORN SHEATH MATERIAL WAS CAUGHT BETWEEN THE TUBES DURING THUMB ADVANCEMENT. THIS FINDING INDICATES, ALTHOUGH NOT REPORTED, THE DEVICE ENCOUNTERED RESISTANCE DURING DEPLOYMENT. THE INTERNAL COMPONENTS WERE EXAMINED AND WERE IN THE CORRECT POST DEPLOYED POSITIONS AND UNDAMAGED. NO PRODUCT DEFICIENCY WAS DETECTED. TO ASSURE THAT THE SHEATH PERFORMS TO SPECIFICATION THEY ARE INSPECTED WHEN RECEIVED AND AGAIN DURING FINAL ACCEPTANCE INSPECTION OF THE FINAL GOODS. A POSSIBLE CAUSE FOR THE EXCHANGE SHEATH STRETCHING IS A TIGHT TISSUE TRACT. INSTEAD OF THE TUBESET SLIDING EASILY WITHIN THE SHEATH, TISSUE COMPRESSION FORCES MAY CAUSE THE SHEATH TO DRAG ALONG WITH THE TUBESET AS IT IS DISTALLY ADVANCED. SUBSEQUENTLY, THE SHEATH ELONGATES WHICH CAN CAUSE INTERFERENCE WITH CLIP DEPLOYMENT. PER THE INSTRUCTIONS FOR USE, IT IS NECESSARY TO CREATE A 5-7 MM SKIN INCISION AT THE SHEATH SITE TO ACCOMMODATE THE INSERTION OF THE CLIP DELIVERY TUBE INTO THE TISSUE TRACT. THIS SHOULD BE DONE AT THE BEGINNING OF THE PROCEDURE PRIOR TO THE ADMINISTRATION OF ANTICOAGULANTS AND ANTIPLATELET AGENTS, IF POSSIBLE. CONSIDER BLUNT DISSECTION BY SINGLE SPREAD WITH A SURGICAL INSTRUMENT IN THE SKIN INCISION. OTHER CONTRIBUTING FACTORS INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING AND DEPLOYMENT IN A CHALLENGING ANATOMY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO PREVIOUS INCIDENTS REPORTED FOR DEVICE OPERATING DIFFERENTLY THAN EXPECTED OR SHEATH SPLIT FOR THIS LOT. BASED ON THE INVESTIGATION OF THE DEVICE, INSPECTION CRITERIA AND THE REPORTED INFORMATION, THE REPORTED DIFFICULTY EXPERIENCED DURING SHEATH SLITTING APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE PRODUCT. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING AND A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    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 OCCURING ABOUT A WEEK AGO). 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.

    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, AFTER THE THUMB ADVANCER WAS DEPLOYED, THE SHEATH DID NOT COMPLETELY SPLIT AND WAS OBSERVED TO BE SHREDDED, BUT INTACT. MANUAL ARTERIAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 950346H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention