BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC QUANTUM APEX BALLOON CATHETER

    MDR report key: 2072136 · Received April 28, 2011

    Report

    Report Number
    2134265-2011-01566
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 6, 2011
    Report Date
    March 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THROMBOSIS OCCURRED. THE PATIENT PRESENTED DUE TO ACUTE CORONARY SYNDROME WITH RECURRENT ANGINA PECTORIS, A POSITIVE STRESS TEST AND HYPOTENSION. ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY USING A NON-BSC SIDEHOLE GUIDE CATHETER AND A NON-BSC 0.014" GUIDE WIRE. CARDIAC CATHETERIZATION REVEALED AN 80-99% STENOSED LESION LOCATED IN THE RIGHT CORONARY ARTERY (RCA) WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. A 1.5X15MM APEX BALLOON WAS ADVANCED AND INFLATED, FOLLOWED BY A 2.0X20MM APEX BALLOON WHICH WAS INFLATED IN THE MID AND PROXIMAL VESSEL WITH IMPROVEMENT TO FLOW NOTED. THEN A 2.25X32MM TAXUS ATOM LIBERTE STENT WAS ADVANCED AND DEPLOYED JUST PAST THE CRITICAL LESION DISTALLY AT 9ATM FOR 30 SECONDS, THEN INFLATED AGAIN TO 12 ATM FOR 30 SECONDS. A 2.5X12MM TAXUS LIBERTE STENT WAS PLACED AND DEPLOYED PROXIMALLY AND OVERLAPPING TO THE PREVIOUS STENT. USING A MAILMAN GUIDE WIRE, A 2.5X20MM QUANTUM APEX BALLOON WAS ADVANCED AND INFLATED TO 18ATM DOWN TO THE END OF THE PROXIMAL STENT. AT THAT TIME THE PHYSICIAN OPTED TO END THE PROCEDURE DUE TO CONTRAST EXPOSURE. THE PATIENT RETURNED THE NEXT DAY FOR A STAGED PROCEDURE TO THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). ACCESS WAS GAINED VIA THE LEFT FEMORAL ARTERY. DURING ANGIOGRAPHY, IT WAS NOTED THAT THE RCA HAD REOCCLUDED JUST PROXIMAL TO THE PREVIOUSLY PLACED STENT WHERE AN EDGE DISSECTION HAD OCCURRED AND LED TO THROMBOSIS. PER THE PHYSICIAN, THE DISSECTION WAS CAUSED BY THE POST DILATION OF THE STENT PERFORMED THE PREVIOUS DAY. AN AL-1 GUIDE CATHETER WAS USED AND A 0.014" NON-BSC GUIDE WIRE CROSSED TO THE DISTAL RCA AND A 1.5X20MM APEX BALLOON WAS ADVANCED AND INFLATED IN THE LESION. BUT DUE TO POOR SUPPORT AND DIFFICULTY CANNULATING, THE GUIDE CATHETER WAS SWITCHED TO A WILLIAMS RIGHT SIDEHOLE 6F GUIDE CATHETER AND THEN A 2.0X20MM APEX BALLOON WAS ABLE TO BE ADVANCED AND INFLATED. A 2.5X24MM TAXUS LIBERTE STENT WAS THEN DEPLOYED IN THE RCA ACROSS THE PROXIMAL EDGE DISSECTION AT 10ATM FOR 30 SECONDS AND 14 ATMS FOR 20 SECONDS. A 2.5X20MM APEX BALLOON WAS USED FOR POST DILATION AT 12ATM. THE LAD WHEN THEN SUCCESSFULLY TREATED WITH A CUTTING BALLOON AND DEPLOYMENT OF A 3.0X38MM TAXUS LIBERTE STENT AND A 3.5X20MM TAXUS LIBERTE STENT. THERE WERE NO OTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC QUANTUM APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE UNK651

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R MAILMAN GUIDE WIRE| KSR SIDEHOLE GUIDE CATHETER| 0.014" PILOT GUIDE WIRE| 2.0X20MM APEX BALLOON| 1.5X15MM APEX BALLOON| 2.25X32MM TAXUS LIBERTE STENT| 2.5X12MM TAXUS LIBERTE STENT