BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUMEN BLUSHEATH DELIVERY CATHETER

    MDR report key: 972942 · Received December 27, 2007

    Report

    Report Number
    3004857433-2007-00002
    Event Type
    Malfunction
    Date Received
    December 27, 2007
    Date of Event
    November 30, 2007
    Report Date
    December 27, 2007
    Manufacturer
    ACUMEN MEDICAL, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS DETERMINED BY LATER INSPECTION DURING THE CASE, AFTER REMOVAL FROM THE PATIENT, THE DISTAL NON-BRAIDED TIP PORTION HAD SPLIT ALONG A DIAMETRICAL LINE, ROUGHLY DIVIDING THE CIRCUMFERENCE IN HALF, AND HALF OF THE TIP HAD BEEN DEFLECTED TO THE SIDE. THE PATIENT DID NOT EXPERIENCE ADVERSE CLINICAL SEQUELAE DUE TO THE MISSING FRAGMENT OF RADIOPAQUE TIP OR THE DISSECTION OF THE CORONARY SINUS.

    Description of Event or Problem · 1

    BLUESHEATH DEVICE LOT H07-0120, A DEVICE WHICH WAS EXPIRED AT THE TIME OF USE (EXPIRED ON 11/01/07) WAS USED FOR A CRT-D UPGRADE. THE BLUSHEATH WAS INSERTED INTO THE SUBCLAVIAN WITHOUT USING AN INTRODUCER. THE PHYSICIAN NOTICED SOME RESISTANCE GETTING THROUGH THE SUBCLAVIAN, AND ONCE IN THE ATRIUM A FLUOROSCOPE IMAGE REVEALED A FLAP HANGING OFF THE DISTAL TIP OF THE DEVICE. DESPITE THIS OBSERVED DEFECT, THE PHYSICIAN CHOSE TO PROCEED AND CANNULATED THE CORONARY SINUS. HE FELT RESISTANCE ADVANCING THE BLUESHEATH INTO THE CORONARY SINUS, AND AFTER SOME ATTEMPTS TO PUSH THROUGH, HE REMOVED THE BLUESHEATH. UPON REMOVAL OF THE BLUESHEATH, THE PHYSICIAN NOTED THAT THE TIP PORTION WHICH WAS PREVIOUSLY DEFLECTED TO THE SIDE WAS NOW MISSING (1/16" BY 180 DEGREES OF 8F CATHETER). FLUOROSCOPY SHOWED A PIECE OF RADIOPAQUE MATERIAL LODGED IN THE SUBCLAVIAN VEIN NEAR THE ACCESS SITE. THE PHYSICIAN DECIDED NOT TO ATTEMPT A RETRIEVAL. THE PROCEDURE CONTINUED USING A MEDTRONIC ATTAIN SHEATH. A VENOGRAM PERFORMED WITH A BALLOON CATHETER THEREAFTER SHOWED THAT THE CORONARY SINUS HAD BEEN DISSECTED. THE PHYSICIAN THEREFORE ABANDONED LV LEAD PLACEMENT. HIS OFFICIAL CASE REPORT STATED THAT THERE WAS NO EXPECTED HARM TO THE PATIENT. HE EXPECTS THE CORONARY SINUS TO HEAL SUFFICIENTLY QUICKLY TO SCHEDULE ANOTHER ATTEMPT AT LV LEAD PLACEMENT IN 2-3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUMEN BLUSHEATH DELIVERY CATHETER INTRODUCER CATHETER (PRODUCT CODE DYB) DYB ACUMEN MEDICAL, INC. BLS-9-45 H07-0120

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR