BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER

    MDR report key: 1002291 · Received February 22, 2008

    Report

    Report Number
    2134265-2008-00526
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    PMA / PMN Number
    K960501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) TREATMENT PROCEDURE, A VESSEL DISSECTION OCCURRED. THE LESION WAS A CHRONIC TOTAL OCCLUSION (CTO) WITHOUT CALCIFICATION, IN THE RIGHT AND LEFT COMMON ILIAC ARTERY (CIA) AND EXTERNAL ILIAC ARTERY (EIA). A 6F "PARENT" INTRODUCER SHEAT (UNK MFR) WAS INSERTED VIA THE LEFT BRACHIAL ARTERY, AND ANOTHER MFR'S GUIDE WIRE WAS ADVANCED TO THE LESION (LEFT CIA-EIA). ANOTHER 6F 10CM SHEATH (UNK MFR) WAS INSERTED VIA THE LEFT FEMORAL ARTERY AND A SNARE WAS ADVANCED AND USED TO PULL THE GUIDE WIRE PAST THE LESION AND THROUGH THE 6F FEMORAL SHEATH. A 4.0 X 40 WANDA WAS ADVANCED TO THE LESION AND INFLATED; HOWEVER, IT RUPTURED AT 8 ATMS. THE BALLOON WAS EXCHANGED FOR A 3.0 X 20 WANDA AND DILATED, AND EXCHANGED ONCE MORE FOR A 6.0 X 80 WANDA AND DILATED. SUBSEQUENTLY, AN 8.0 X 10 CM NON BSC STENT AND A 10 X 6.0 CM NON BSC STENT WERE PLACED. FOLLOWING TREATMENT OF THE LEFT CIA-EIA, THE LESION IN THE RIGHT CIA-EIA WAS TREATED. TWO DIFFERENT NON BSC GUIDE WIRES WERE ADVANCED TO THE LESION, AND THEN WERE REPLACED WITH A THRUWAY GUIDEWIRE (SIZE UNK). THE LESION WAS THEN DILATED WITH A 4.0 X 2.0 CM SYMMETRY BALLOON AND A 6.0 X 4.0 SYMMETRY. FOLLOWING BALLOON DILATATION, A 10 X 10CM NON BSC STENT AND AN 8.0 X 8.0 CM NON BSC STENT WERE PLACED. BOTH STENTS WERE POST DILATED WITH A NON BSC BALLOON CATHETER; HOWEVER, IT RUPTURED. THE BALLOON CATHETER WAS EXCHANGED FOR ANOTHER OF THE SAME DEVICE AND THE LESION WAS POST DILATED. THE PHYSICIAN THEN NOTED UNDER ANGIOGRAPHY THAT THE STENT PLACED IN THE LEFT EIA HAD NOT FULLY EXPANDED. THE ULTRA THIN DIAMOND BALLOON CATHETER WAS THEN ADVANCED TO THE LESION AND THE STENT WAS POST DILATED. SUBSEQUENTLY, A DISSECTION OCCURRED AT THE DISTAL PORTION OF THE STENT. BLOOD FLOW IN THE COMMON FEMORAL ARTERY (CFA) AND SUPERFICIAL FEMORAL ARTERY (SFA) STOPPED. A NON BSC GUIDE WIRE WAS USED IN AN ATTEMPT TO CROSS THE LESION FROM AN ANTEROGRADE APPROACH; HOWEVER, IT WAS UNSUCCESSFUL. A 4F SHEATH (UNK MFR) WAS INSERTED VIA THE LEFT POPLITEAL ARTERY, AND THEN THE NON BSC GUIDE WIRE WAS ABLE TO CROSS THE LESION VIA THE RETROGRADE APPROACH. A 4.0 X 40 NON BSC BALLOON CATHETER WAS ADVANCED TO THE LESION AND INFLATED; HOWEVER, THE BALLOON WAS TOO SMALL. THEREFORE, THE BALLOON WAS EXCHANGED FOR A 5.0 X 40 NON BSC BALLOON AND THE DISSECTION WAS "LONG INFLATED". THE PROCEDURE WAS TERMINATED. NO FURTHER PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS IS LISTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC NA 9539147

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention 6 X 10CM SMART STENT| ASTART GUIDE WIRE| 10 X 10 CM LUMINEX STENT| CRUISE GUIDE WIRE| RADIFOCUS GUIDE WIRE| 8 X 10CM SMART STENT| 8 X 8 CM LUMINEX STENT| 7 X 4 SUBMARINE BALLOON CATHETER| 4 X 40 MM| TREASURE GUIDE WIRE