BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2023882 · Received March 18, 2011

    Report

    Report Number
    2024168-2011-01816
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED DEPLOYED, AS EVIDENCED BY THE PRESENCE OF BLOOD IN THE DEVICE. THE PLUNGER, CUFFS, NEEDLE TIP, LINK AND MONOFILAMENT WERE NOT RETURNED. EVALUATION OF THE RETURNED BODY COMPONENTS OF THE DEVICE WAS PERFORMED. HANDLE TO FOOT FUNCTION AND INSPECTION OF THE GUIDE TUBE, NEEDLE GUIDE, BRIDGE, SUTURE BEARING, EXIT RAMP AND SHEATH COMPONENTS WERE NORMAL. SINCE ONLY THE BODY OF THE DEVICE WAS RETURNED, THE REPORTED EVENT COULD NOT BE FULLY EVALUATED. THE PROBABLE CAUSE FOR THE SUTURE BEING PULLED OUT OF THE ARTERY IS NOT ENOUGH TISSUE CAPTURE DURING NEEDLE DEPLOYMENT OR, GIVEN THE REPORT OF MINIMAL BLOOD RETURNED IN THE MARKER LUMEN, THE DEVICE WAS POTENTIALLY DEPLOYED OUTSIDE THE ARTERY. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR DIFFICULTY INSERTING THE SHEATH OR KINK DAMAGE WITH THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4): USE IN A CALCIFIED VESSEL, DEVICE DEPLOYED WITHOUT A CONTINUOUS DRIP OF BLOOD EVIDENT FROM THE MARKER LUMEN. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. DEVICE #1 PROGLIDE IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A MODERATELY SCARRED AND MILDLY CALCIFIED COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC CORONARY ANGIOGRAPHIC PROCEDURE. REPORTEDLY, DURING DEVICE INSERTION, DIFFICULTY WAS ENCOUNTERED AND ARTERIAL LUMINAL MARKING COULD NOT BE ACHIEVED. THE DEVICE WAS REMOVED OVER A GUIDE WIRE REVEALING A KINK DISTAL TO THE FOOT. IT WAS BELIEVED THAT THE DEVICE KINKED DUE TO SCAR TISSUE AT THE GROIN SITE AND ADDITIONAL PRESSURE THAT WAS APPLIED TO ADVANCE THE DEVICE. A SECOND PROGLIDE DEVICE WAS ATTEMPTED, BUT ALTHOUGH ONLY MINIMAL BLOOD WAS OBSERVED FROM THE MARKER LUMEN, DEVICE DEPLOYMENT WAS ATTEMPTED; HOWEVER, THE SUTURES DID NOT CAPTURE ARTERIAL TISSUE. A HEMATOMA LESS THAN 5MM AND TENDERNESS DEVELOPED AT THE GROIN SITE. MANUAL COMPRESSION WAS USED TO EXPRESS THE HEMATOMA AND ACHIEVE HEMOSTASIS. A COMPUTED TOMOGRAPHY SCAN WAS NEGATIVE FOR A RETROPERITONEAL HEMORRHAGE. THE PATIENT WAS MONITORED OVERNIGHT, THE TENDERNESS RESOLVED, AND THE PATIENT WAS DISCHARGED TO HOME THE NEXT DAY. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: ALTHOUGH IT WAS INITIALLY REPORTED THAT A HEMATOMA LESS THAN 5MM DEVELOPED AT THE GROIN SITE, NEW INFORMATION RECEIVED INDICATES THE HEMATOMA WAS LARGER THAN INITIALLY REPORTED; THE SIZE WAS NOT SPECIFIED. HOSPITALIZATION WAS EXTENDED A FEW DAYS AND THE PATIENT WAS DISCHARGED TO HOME. A FEW DAYS LATER THE PATIENT RETURNED. CT SCAN REVEALED A PSEUDOANEURYSM THAT WAS TREATED WITH THROMBIN INJECTION. THE PATIENT WAS SENT HOME. THE PATIENT RETURNED AGAIN COMPLAINING OF GROIN AND LEG PAIN. CT SCAN WAS DONE. NO PULSES WERE FOUND IN THE LEG. A CLOT WAS SURGICALLY REMOVED FROM BEHIND THE KNEE. POST-OPERATIVELY, DIMINISHED PULSES WERE FOUND IN THE FOOT, HOWEVER, NO TREATMENT WAS GIVEN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 970046H

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R