BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 1040078 · Received May 7, 2008

    Report

    Report Number
    3004742232-2008-00003
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    March 27, 2008
    Report Date
    March 27, 2008
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCW
    PMA / PMN Number
    K071427
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE DEVICE WAS NOT RETURNED FOR EXAMINATION, THEREFORE, AN ANALYSIS OF THE ACTUAL COMPLAINT DEVICE IS NOT POSSIBLE. THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE DEVICE MET ITS MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS. THE ROOT CAUSE FOR THE REPORTED EVENT IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OUTPATIENT PTA AND ATHERECTOMY TREATMENT PROCEDURE, HEMOLYSIS OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WHICH DEMONSTRATED A REFERENCE VESSEL DIAMETER OF 5.5 MILLIMETERS. THE LESION WAS 100% OCCLUDED, MILDLY CALCIFIED AND MEASURED 6-7 CENTIMETERS IN LENGTH. USING A 7F INTRODUCER SHEATH FROM A RIGHT FEMORAL ACCESS SITE, THE PHYSICIAN USED A 2.25 MM SOLID-CROWN ORBITAL ATHERECTOMY DEVICE (OAD) WITH A 0.014" VIPERWIRE GUIDE WIRE TO CROSS THE DISTAL SFA LESION. HE PERFORMED MULTIPLE PASSES WITH THE OAD TO TREAT THE TARGET LESION FOR A TOTAL INTERVENTION TIME OF 8 MINUTES, 9 SECONDS. HE SUBSEQUENTLY PERFORMED LOW PRESSURE BALLOON ANGIOPLASTY WITH A 6 MM BALLOON DILATATION CATHETER AT 4 ATMS FOR 120 SECONDS OVER A 15 CM SEGMENT OF THE DISTAL SFA. THE FINAL ANGIOGRAM REVEALED "AN EXCELLENT RESULT" WITH SOME RESIDUAL LUMINAL IRREGULARITY, BUT NO SIGNIFICANT RESIDUAL OBSTRUCTIVE DISEASE. BRISK THREE-VESSEL RUNOFF TO THE RIGHT FOOT WAS NOTED FOLLOWING THE INTERVENTION. THE PT TOLERATED THE PROCEDURE WELL WITH 1+ POST-PROCEDURE DORSALIS PEDIS AND POST-TIBIAL PULSES ON BOTH THE RIGHT AND LEFT. THE PT WAS NOTED TO HAVE HEMOGLOBINURIA POST-PROCEDURE. THE PHYSICIAN TREATED THE PT WITH INTRAVENOUS FLUIDS AND OVERNIGHT OBSERVATION. THE HEMOGLOBINURIA RESOLVED AND THE PT WAS DISCHARGED TO HOME THE FOLLOWING DAY. NO ADD'L INTERVENTION OR FOLLOW-UP WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM MCW CARDIOVASCULAR SYSTEMS, INC. DB-SC-225L

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| O| R 6X10X110MM CORDIS OPTA PRO BALLOON DILATATION CATH| 7F/45CM TERUMO DESTINATION INTRODUCER SHEATH