BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2941558 · Received February 4, 2013

    Report

    Report Number
    2024168-2013-00604
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE PLUNGER AND THE LINK WERE NOT RETURNED WITH THE DEVICE. THE REPORTED EVENT WAS NOT CONFIRMED. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT A KNOT LOCK OCCURRED DURING KNOT ADVANCEMENT. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ONE UNUSED STERILE PROGLIDE DEVICE WITH THE SAME LOT NUMBER, 21126J1, AS THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED AND THE DEVICE PASSED WITH ACCEPTABLE RESULTS. NO MANUFACTURING OR ABNORMAL OBSERVATIONS WERE DETECTED. A CAUSE FOR THE COMPLAINT DEVICE REPORTED EXPERIENCE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED SAMPLE. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). ESTIMATED DATE OF OCCURRENCE, EXACT DATE IS UNKNOWN (REPORTED AS OCCURRED IN WEEK OF (B)(6) 2013). THE NEXT DAY, THE ABDOMINAL WAS FAT AND THE PATIENT DEVELOPED ACIDOSIS. BRADYCARDIA AND ULTIMATELY ASYSTOLE OCCURRED. REPORTEDLY, THE PATIENT DIED FROM PROTRACTED SHOCK AFTER BLEEDING WITH PRE-RENAL KIDNEY FAILURE. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION. A WRITTEN CONSENT HAS NOT BEEN OBTAINED IN THIS CASE, THEREFORE, THIS INFORMATION ARE NOT AVAILABLE. CONCOMITANT MEDICAL PRODUCTS: SHEATH: 6F, GUIDE WIRE: .035, BIVALIRUDIN, EFFIENT. 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. THE ADDITIONAL TWO PROGLIDE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER A CORONARY ARTERY STENTING PROCEDURE. DURING THE INTERVENTIONAL PROCEDURE THE PATIENT HAD RECEIVED BIVALIRUDIN IC (170 CM /49 KG) AND EFFIENT 60 MG. REPORTEDLY, THE DEVICE HAD BEEN INTRODUCED OVER A STANDARD GUIDE WIRE. THE GUIDE WIRE WAS REMOVED AT SKIN LEVEL AND THE DEVICE PUSHED FORWARD UNTIL BLOOD MARKING WAS VISIBLE FROM THE MARKER LUMEN. THE DEVICE WAS THEN PULLED BACK UNTIL THERE WAS NO MORE MARKING VISIBLE. NO PROBLEM WAS NOTED DURING NEEDLE DEPLOYMENT; HOWEVER, WHEN GENTLY PULLING ON THE BLUE RAIL SUTURE, THE COMPLETE SUTURE CAME OUT IN THE OPERATOR'S HAND. A SECOND PROGLIDE DEVICE WAS USED WITH THE SAME RESULTS. A THIRD PROGLIDE DEVICE WAS USED AND AFTER FOOT DEPLOYMENT THE DEVICE WAS PULLED BACK TO PLACE THE FOOT AGAINST THE ARTERIAL WALL; HOWEVER, THE DEVICE PULLED OUT OF THE ARTERIOTOMY AND ONCE THE DEVICE WAS OUT IT WAS FOUND THE FOOT REMAINED OPENED. HEMOSTASIS WAS BELIEVED TO HAVE BEEN ACHIEVED AFTER 90 MINUTES OF MANUAL ARTERIAL COMPRESSION; NO BLEEDING WAS VISIBLE. A COMPRESSION BANDAGE WAS PLACED AND THE PATIENT WAS THEN TAKEN TO THE INFIRMARY. APPROXIMATELY 7 HOURS AFTER THE INTERVENTIONAL PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE AND RETROPERITONEAL BLEEDING WAS CONFIRMED. THE PATIENT REQUIRED RESUSCITATION AND WAS INTUBATED. THE VASCULAR SURGEON NOTED TWO HOLES IN THE COMMON FEMORAL ARTERY AND A PATCH WAS PLACED ON THE ARTERY. THE PATIENT RECEIVED MEDICATION, CATECHOLAMINE, 5 UNITS RED BLOOD CELLS AND 3 UNITS FRESH FROZEN PLASMA. RENAL FAILURE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46159 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21126J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention