BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2191645 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05486
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. REPORTED DEVICE (B)(4) INDICATION FOR USE. THE STARCLOSE SE DEVICE WAS DEPLOYED AFTER COMPLETION OF A DIAGNOSTIC PERIPHERAL ANGIOGRAM THROUGH A 4F PROCEDURAL SHEATH, WHICH MAY HAVE DIMINISHED THE OPERATORS TACTILE FEEDBACK CAUSING THE DEVICE TO BE PULLED OUT FROM THE ARTERY. THE DEVICE IS INDICATED FOR PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS, AMBULATION, AND DISCHARGEABILITY IN PATIENT WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR AND INTERVENTIONAL CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT AFTER UNEVENTFUL COMPLETION OF THUMB ADVANCER DEPLOYMENT AND EXCHANGE SHEATH SPLITTING, WHEN THE DEVICE WAS RAISED TO DEPLOY THE CLIP, THE DEVICE PULLED OUT FROM THE ARTERIOTOMY SITE LOSING VESSEL ACCESS. IN ADDITION, THE STARCLOSE SE DEVICE CLIP WAS FOUND DEPLOYED ON THE DISTAL END OF THE DEVICE. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. LOSS OF ARTERIAL ACCESS AND MISLODGED/MISLOCATED CLIP CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO A MANUFACTURING, USER TECHNIQUE AND, PATIENT ANATOMICAL CONDITIONS, EACH WERE CONSIDERED. A FEMORAL ANGIOGRAM WAS TAKEN AND REVEALED NO PRESENCE OF VESSEL CALCIFICATION, VESSEL TORTUOSITY, OR ACCESS SITE/GROIN SCARRING. NO OTHER INFORMATION REGARDING PATIENT ANATOMICAL CONDITIONS WAS PROVIDED. LOSS OF ARTERIAL ACCESS CAN OCCUR DUE TO THE FOLLOWING, INCOMPLETE STROKE OF PLUNGER (CLICK 2), APPLYING EXCESSIVE TENSION AGAINST THE LOCATOR WINGS, OR INADEQUATE NICK AND SPREAD MAY RESULT N LOSS OF ARTERIAL ACCESS. IN REGARDS TO THE MISLODGED/MISLOCATED CLIP, INADEQUATE NICK AND SPREAD, IMPROPER SEATING OF THE CLIP DELIVERY TUBE ON TOP OF THE ACCESS SITE, NOT MAINTAINING DOWNWARD PRESSURE AND DEVICE STABILITY WHILE DEPRESSING THE DEPLOYMENT BUTTON WITH THE RIGHT THUMB, INCORRECT ANGLE OF THE DEVICE DURING CLIP DEPLOYMENT (CLICK 4), WHICH SHOULD BE 60-75 DEGREES, AND RETRACTION OF THE DEVICE DURING CLIP DEPLOYMENT (CLICK 4), MAY CAUSE A MISLODGED/MISLOCATED CLIP. NO INFORMATION CONCERNING USER TECHNIQUE WAS PROVIDED IN THIS CASE. STARCLOSE SE DEVICE INSTRUCTION FOR USE (IFU) UNDER INDICATIONS FOR USE STATES THAT THE DEVICE IS INDICATED FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH. THEREFORE, THE OFF-LABEL USE OF THE DEVICE (4FR SHEATH) MAY HAVE CONTRIBUTED TO THE REPORTED LOSS OF ARTERIAL ACCESS AND THE MISLODGED/MISLOCATED CLIP. PRODUCT WAS NOT RETURNED FOR ANALYSIS, WHICH MAY HAVE ASSISTED IN THE INVESTIGATION; THEREFORE, A CONCLUSIVE CAUSE FOR THE REPORTED LOSS OF ARTERIAL ACCESS AND MISLODGED/MISLOCATED CLIP CANNOT BE DETERMINED. HOWEVER, THE OFF-LABEL USE OF THE DEVICE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE ARE NO SIMILAR INCIDENTS FOR THIS LOT. 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 AN INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DIAGNOSTIC PERIPHERAL ANGIOGRAM THROUGH A 4F PROCEDURAL SHEATH, ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A STARCLOSE SE DEVICE. REPORTEDLY, AFTER UNEVENTFUL COMPLETION OF THUMB ADVANCER DEPLOYMENT AND EXCHANGE SHEATH SPLITTING, WHEN THE DEVICE WAS RAISED TO DEPLOY THE CLIP, THE DEVICE PULLED OUT FROM THE ARTERIOTOMY SITE LOSING VESSEL ACCESS. IN ADDITION, THE STARCLOSE SE DEVICE CLIP WAS FOUND DEPLOYED ON THE DISTAL END OF THE DEVICE. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. 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 040406H

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention PROCEDURAL SHEATH 4F