BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 2231163 · Received August 25, 2011

    Report

    Report Number
    2182269-2011-00136
    Event Type
    Injury
    Date Received
    August 25, 2011
    Report Date
    August 25, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. THE COMPLAINT PRODUCT USED MAY HAVE BEEN FROM EITHER LOT 3347594 OR 3352532. THE MFG DATES FOR BOTH LOT NUMBERS IS 01 MAR 2011 AND THE USE BY/USE BEFORE DATE FOR BOTH LOTS IS 29 FEB 2012. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED BOTH OF THESE LOTS MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFORMATION PROVIDED TO ST. JUDE MEDICAL, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT BLEEDING OR A HEMATOMA AT THE PUNCTURE SITE IS A POSSIBLE RISK OR SITUATION THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE OR VASCULAR ACCESS PROCEDURES. IF THIS SHOULD OCCUR, THE IFU INSTRUCTS THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE. IF NECESSARY, MONITOR PEDAL PULSES. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTIONS, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) WARNS THAT FAILURE TO MAINTAIN TENSION ON THE SUTURE WHILE ADVANCING THE COLLAGEN COULD CAUSE THE COLLAGEN TO ENTER THE ARTERY. THE ANGIO-SEAL DEVICE PT'S INFO GUIDE, WHICH THE PT IS INSTRUCTED TO CARRY WITH THEM FOR 90 DAYS STATES SOME BRUISING OR DISCOMFORT IS COMMON DURING THE HEALING PROCESS AFTER INTRAVASCULAR PROCEDURE; HOWEVER, IF ANY OF THE FOLLOWING SYMPTOMS ARE EXPERIENCED THE PT IS TO CONTACT THEIR PHYSICIAN IMMEDIATELY AT THE NUMBER LISTED ON THEIR PT INFO CARD: FEVER, BLEEDING, PERSISTENT TENDERNESS IN THE GROIN OR SWELLING, REDNESS AND/OR WARM TO TOUCH, NUMBNESS, TINGLING OR PAIN IN THE EXTREMITY WHEN AMBULATING, RASH, WOUND DRAINAGE, OR ANY OTHER UNUSUAL SYMPTOMS.

    Description of Event or Problem · 1

    FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR CHRONIC TOTAL OCCLUSION (CTO), THE PCI WAS ABORTED DUE TO THE GUIDEWIRE NOT BEING ABLE TO CROSS THE CTO LESION. AN 8F ANGIO-SEAL STS PLUS WAS SELECTED FOR USE. A PRE-DEPLOYMENT ANGIOGRAM REVEALED A RIGHT COMMON FEMORAL ARTERY (RCFA) PUNCTURE WITH MILD CALCIFICATION BUT NO STENOSIS. A 7F TERUMO SHEATH WAS USED DURING THE PCI. DURING THE CINCHING PHASE OF DEPLOYMENT, THE PHYSICIAN KEPT TENSION ON THE SUTURE WHILE TAMPING THE COLLAGEN. BEFORE CUTTING THE SUTURE, THE PHYSICIAN RELEASED HIS GRIP. BLEEDING FROM THE PUNCTURE SITE WAS OBSERVED. MANUAL COMPRESSION WAS APPLIED FOR FORTY MINUTES AND HEMOSTASIS WAS ACHIEVED. THE PT WAS DISCHARGED FROM THE HOSP (EXACT DATE UNK). THE PT REPORTED PAIN IN THE RIGHT LEG ABOUT TWO DAYS FOLLOWING DISCHARGE. THE PHYSICIAN CHOSE TO TAKE A WAIT AND SEE APPROACH. THE PT LATER COMPLAINED OF STRONGER PAIN IN THE RIGHT LEG WHEN STANDING. THE PT VISITED THE HOSP AND A MAGNETIC RESONANCE IMAGING (MRI) SCAN WAS PERFORMED. THE MRI REVEALED AN OCCLUSION AT THE ANGIO-SEAL PUNCTURE LOCATION. THE PT HAS BEEN HOSPITALIZED AND A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) FOR THE OCCLUSION HAS BEEN SCHEDULED BUT NOT YET PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R