BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUNWAY GUIDE CATHETER

    MDR report key: 3099484 · Received May 8, 2013

    Report

    Report Number
    2134265-2013-02902
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    January 20, 2012
    Report Date
    April 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K033441
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: CATHETER SIZE CORRECTED FROM FL3.7 TO FL3.5. BRAND NAME CORRECTED FROM EXPO GUIDE CATHETER TO RUNWAY GUIDE CATHETER. COMMON DEVICE NAME CORRECTED FROM CATHETER, INTRAVASCULAR, DIAGNOSTIC TO CATHETER, PERCUTANEOUS. (B)(4). PMA# OR 510K# CORRECTED FROM K992142 TO K033441. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME PATIENT AS MDR ID#: 2134265-2013-02966. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, VESSEL SPASM OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION: IIIB) AND WAS DIAGNOSED WITH NON Q-WAVE MYOCARDIAL INFARCTION. THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE DE NOVO TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MID LAD) WITH 73% STENOSIS AND WAS 6MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 3.00X12MM ION STENT WITH 0% RESIDUAL STENOSIS. DURING THE INDEX PROCEDURE, POST ANGIOGRAPHY INTRAVASCULAR ULTRASOUND (IVUS) OF THE MID LAD WAS PERFORMED USING AN ICROSS IMAGING CATHETER AND A FL3.7 GUIDE CATHETER. AFTER THAT THE PATIENT HAD A SEVERE SPASM DUE TO THE USE OF THE GUIDE CATHETER AND WAS ADMINISTERED WITH IC NITROGLYCERIN. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT DURING THE INDEX PROCEDURE, THE SIZE OF THE GUIDE CATHETER USED WAS 6F FL3.5 INSTEAD OF PREVIOUSLY REPORTED FL3.7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201275 RUNWAY GUIDE CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE UNK382

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention 3.00X12MM ION STENT