BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1161287 · Received September 15, 2008

    Report

    Report Number
    2953144-2008-01486
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 20, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE INDICATION FOR THE USE PER THE PROGLIDE INSTRUCTIONS FOR USE (IFU) IS FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING A COMMON FEMORAL ARTERY ACCESS SITE. THE IFU WARNING SECTION STATES "DO NOT USE THE PERCLOSE PROGLIDE SMC SYSTEM IF THE PUNCTURE SITE IS LOCATED ABOVE THE MOST INFERIOR BORDER OF THE INFERIOR EPIGASTRIC ARTERY (IEA) AND/OR ABOVE THE INGUINAL LIGAMENT BASED UPON BONY LANDMARKS, SINCE SUCH A PUNCTURE SITE MAY RESULT IN A RETROPERITONEAL HEMATOMA. PERFORM A FEMORAL ANGIOGRAM TO VERIFY THE LOCATION OF THE PUNCTURE SITE."

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: FAILURE TO RETRIEVE SUTURE; DIFFICULT TO REMOVE DEVICE. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS, DISSECTION, AND RETROPERITONEAL BLEED. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT EXTERNAL ILIAC ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. IT WAS ALSO REPORTED THE DEVICE WAS DIFFICULT TO REMOVE FROM THE PATIENT'S ARTERY AND THE PHYSICIAN USED FORCE TO SUCCESSFULLY REMOVE THE PROGLIDE DEVICE. SPECIFIC INFORMATION REGARDING THE CAUSE FOR THE DIFFICULT REMOVAL WAS NOT PROVIDED. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. APPROXIMATELY ONE TO TWO HOURS POST PROCEDURE THE PATIENT REPORTED LEG PAIN AND WAS TAKEN BACK TO THE CATH LAB. AN ANGIOGRAM WAS TAKEN THROUGH CONTRALATERAL ACCESS AND A SPIRAL DISSECTION WAS FOUND IN THE RIGHT EXTERNAL ILIAC ARTERY WITH INHIBITED FLOW TO THE LEG BELOW THE KNEE. THE DISSECTION WAS TREATED USING A NON-ABBOTT BALLOON, STENT AND ANGIOJET. THE PATIENT REPORTED EXPERIENCING BACK AND ABDOMINAL PAIN. HIS ABDOMEN WAS REPORTEDLY "HARD TO THE TOUCH". THE PATIENT'S HEMOGLOBIN COUNT WAS 4 MG/DL AND A RETROPERITONEAL BLEED (RPH) WAS FOUND. SPECIFIC INFORMATION REGARDING TREATMENT OF THE RETROPERITONEAL BLEED WAS NOT PROVIDED. THE PATIENT RECEIVED 10 UNITS OF BLOOD. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR REDWOOD CITY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| L| R SHEATH: 6 FR