BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1823392 · Received August 25, 2010

    Report

    Report Number
    3003681312-2010-00057
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    June 1, 2010
    Report Date
    August 25, 2010
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO PROVIDED TO ST. JUDE MEDICAL, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. 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 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 PROCEDURES; 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

    IT WAS REPORTED THAT AN ANGIO-SEAL VIP WAS SELECTED FOR USE POST DIAGNOSTIC CORONARY ANGIOGRAM. A PRE-INSERTION ANGIOGRAM SHOWED THE FEMORAL ARTERY TO BE OF A GOOD SIZE AND FREE FROM CALCIFICATION. THE ANGIO-SEAL WAS DEPLOYED WITHOUT DIFFICULTIES AND THE PT HAD PALPABLE PEDAL PULSES AFTER THE PROCEDURE. APPROXIMATELY THREE WEEKS LATER, THE PT RETURNED TO THE HOSPITAL FOR A PACEMAKER PROCEDURE. DURING PRE-OPERATIVE CHECKS, THE STAFF OBSERVED THE PT TO HAVE AN ISCHEMIC RIGHT LEG, AND NO PEDAL PULSES. ON (B)(6) 2010, THE PT HAD A DIAGNOSTIC PERIPHERAL ANGIOGRAM WHICH REVEALED AN OCCLUDED COMMON FEMORAL ARTERY AT THE LOCATION OF WHERE THE ANGIO-SEAL HAD BEEN PLACED. TWO DAYS LATER, THE PT HAD AN ANGIOPLASTY. THE PT IS SCHEDULED FOR SURGICAL ENDARTERECTOMY. THE EVENT DATE IS MONTH SPECIFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VASCULAR CLOSURE DEVICE MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. NA 2871666

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R