BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1966488 · Received January 21, 2011

    Report

    Report Number
    2024168-2011-00407
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    December 18, 2010
    Report Date
    December 27, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (2) APEX, QUANTUM MAVERICK, GLIDE WIRE, (2) BMW UNIVERSAL WIRE, EXTRA BACK-UP GUIDE CATHETER, (2) INTERNAL MAMMARY CATHETER, AR-1 6-F, PIGTAIL 5-F, PIGTAIL 4-F, JL4, AR MODIFIED CATHETER 7-F, PINNACLE DESTINATION TERUMO 7-F, (2) RX MINI VISION STENTS, HEMASHIELD DARON PATCH, FOGARTY CLAMP, CUPPED FORCEPS, ANGIOMAX, PROPOFOL, ADENOSINE, NITROGLYCERIN, DOPAMINE, NEOSYNEPHRINE, FENTTANYL, ISOVUE THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THERE WERE EXCELLENT DOPPLER SIGNALS AND HEMOSTASIS ALONG THE REPAIR SITE LOOKED VERY GOOD. TEN DAYS AFTER THE PROCEDURE, THE PATIENT EXPIRED FROM HEART FAILURE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE PHYSICIAN STATED THAT THE DEATH WAS NOT RELATED TO THE PROGLIDE DEVICE, BUT THE PATIENT HAD SEVERE PRE-EXISTING CARDIAC VASCULAR DISEASE.

    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 HEAVILY CALCIFIED RIGHT COMMON FEMORAL ARTERY (RCFA) AFTER AN EMERGENT INTERVENTIONAL PROCEDURE. REPORTEDLY, ALTHOUGH THE RCFA ANGIOGRAM REVEALED HEAVY PERIPHERAL VASCULAR DISEASE, THE PHYSICIAN CONSIDERED THE VESSEL SUITABLE FOR ATTEMPTING USE OF THE PERCLOSE DEVICE. AFTER ADVANCING THE DEVICE THROUGH THE ARTERIOTOMY, IT BECAME STUCK AND UNABLE TO BE REMOVED. IT WAS SUSPECTED THAT THIS WAS SECONDARY TO PLAQUE OR DEBRIS PREVENTING CLOSURE OF THE FOOTPLATE. THE DEVICE WAS ADVANCED FURTHER, ATTEMPTING TO REMANIPULATE THE FOOTPLATE. HOWEVER, THE DEVICE WAS STILL UNABLE TO BE REMOVED. WITH SOME GENTLE TRACTION, THE DEVICE FINALLY RELEASED; HOWEVER, THE FOOTPLATE REMAINED OPEN, AND LIKELY RESULTED IN PERFORATION OF THE RCFA. THE PATIENT BECAME HYPOTENSIVE, AND ACCESS WAS LOST TO THE VESSEL. THE ANGIOMAX HAD ALREADY BEEN DISCONTINUED AND IMMEDIATE PRESSURE WAS PLACED ON THE RIGHT GROIN. THE PATIENT WAS AGGRESSIVELY VOLUME RESUSCITATED WITH IV FLUIDS AND ADMINISTRATION OF PACKED RED BLOOD CELLS, DUE TO THE FACT THE PATIENT WAS IN CRITICAL CONDITION AT THE ONSET OF THE CASE AND RAPIDLY HYPOTENSIVE. O-NEGATIVE UNCROSSED-MATCHED BLOOD WAS INITIALLY ADMINISTERED, BUT LATER STOPPED WHEN THE PATIENT STABILIZED. AN ATTEMPT TO STOP THE BLEEDING WITH A BALLOON OCCLUSION AND POSSIBLE USE OF A COVERED STENT WAS UNSUCCESSFUL DUE TO THE SHEATH BEING UNABLE TO CROSS A STENOSIS IN THE LCFA. IT WAS DECIDED TO PROCEED WITH EMERGENT EXPLORATION AND CONTAINMENT OF THE BLEEDING AND PERFORATION. PARTIAL ENDARTERECTOMY OF THE RCFA WAS PERFORMED AND THE VESSEL WAS SURGICALLY REPAIRED AND PATCHED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening| R