BEUDAMED
    FDA Adverse Event Death Summary report: N

    THE CLOSER S 6 FR SMC

    MDR report key: 382062 · Received March 5, 2002

    Report

    Report Number
    2953144-2002-00030
    Event Type
    Death
    Date Received
    March 5, 2002
    Date of Event
    February 1, 2002
    Report Date
    February 4, 2002
    Manufacturer
    PERCLOSE, INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RECEIVED USER FACILITY MANDATORY MMEDWATCH WHICH STATES, "PERCLOSE DEVICE USED AT END OF CARDIAC CATH TO CLOSE FEMORAL ARTERY. PT EXPIRED FROM RETROPERITONEAL BLEED A FEW HOURS LATER." ADD'L INFO RECEIVED: THE M.D. COMPLETED ARTERIOTOMY CLOSURE OF RIGHT GROIN WITH THE CLOSER 6 S DEVICE AFTER AN ANGIOPLASTY PROCEDURE TO THE CIRCUMFLEX ARTERY IN 2002. THE M.D. HAD MINOR DIFFICULTY ACCESSING THE RIGHT GROING DUE TO OBESITY AND LARGE PANUS. ARTERIOTOMY WAS A LITTLE HIGHER THEN NORMAL DUE TO THE LENGTH OF THE TISSUE TRACT TO GET TO THE ARTERY. GROIN SITE REPORTED TO APPEAR "OK ON ANGIOGRAM." MODERATE OZZING AROUND POSITIONER NOTED; THE M.D. HELD POSITIONER IN PLACE FOR 5-10 MIN. THE M.D. ASSESSED THE GROIN SITE WHILE THE PT WAS IN THE HOLDING AREA; SITE WAS REPORTED TO BE "OK". THE M.D. WAS CALLED TO THE CATH LAB TO ACCESS THE GROIN SITE, DIMINISHED PULSES, AND LOW B/P. PT WAS REPORTED TO HAVE NAUSEA AND TACHYCARDIA SYMPTOMS AFTER PROCEDURE. FLUID AND DOPAMINE WERE GIVEN; VASCUALR SURGEON WAS CALLED TO ASSESS THE GROIN SITE. AGAIN THE GROIN WAS REPORTED TO BE "OK". THE PT'S EKG WAS NOTED ST ELEVATION; PT RETURNED TO CATH LAB. VIA A LEFT GROIN ACCESS, AN ANGIOGRAM OF THE RIGHT GROIN DID NOT REVEAL BLEEDING OF THE RIGHT FEMORAL ARTERY. DOPAMINE WAS ON BOARD TO CAUSE VASOCONSTRICTION. A SECOND LESION OR SPASM DISTAL TO THE STENTED ARE WAS FOUND; THIS WAS BALLOONED WITH GOOD RESULTS. THE PT'S HEMOGLOBIN HAD GONE DOWN FROM 15 TO 5. A PA CATH WAS INSERTED; WEDGE PRESSURE WAS 9 AFTER 4L'S OF FLUID. LEFT GROIN SHEATH WAS SEWN IN PLACE. PT'S O2 SAT WAS 70%; PT WAS INTUBATED. A CT SCAN WAS DONE; SHOWED "A LARGE RETROPERITONEAL BLEED." PT WENT TO O.R.; THE RIGHT LEG WAS OPENED. IT WAS NOTED THAT THE SUTURE WAS INTACT. IT WAS DIFFICULT TO DETERMINE IF THE ARTERIOTOMY WAS FULLY OPPOSED OR NOT. THE SUTURE WAS REMOVED; THE ARTERY REPAIRED. IT WAS REPORTED THAT THE ACTUAL ARTERIAL STICK WAS IN THE EXTERNAL ILIAC ARTERY. THE SURGEON HAD TO GO THROUGH THE INGUINAL LIGAMENT TO DO REPAIR. DUE TO THE PT'S OBESITY, THE STICK TRAVELED UNDER THE INGUINAL LIGAMENT AND INTO THE EXTERNAL LIGAMENT. FEMORAL HEAD WAS FLUOROED; STICK WAS AT 45 DEGREE. THE DISTANCE TO THE ARTERY WAS LONGER DUE TO PT SIZE; CAUSING A HIGHER ARTERIOTOMY THAN NORMAL. LEFT GROIN SHEATH WAS REMOVED; LEFT FEMORAL ARTERY WAS SUTURE. THE CAUSE OF BLEEDING WAS NOT FULLY DETERMINED. PT'S B/P NEVER RECOVERED. THE PT EXPIRED IN 2002 AT 4AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE CLOSER S 6 FR SMC SUTURE MEDIATED CLOSURE MGB PERCLOSE, INC. NA 82295-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 8 FR SHEATH, MFR UNSPECIFIED.| DOPAMINE, HEPARIN, INTEGRELIN.