BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MACH1 GUIDE CATHETER

    MDR report key: 2063408 · Received April 19, 2011

    Report

    Report Number
    2134265-2011-01181
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K020028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: 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

    SAME CASE AS MFR #'S: 2134265-2011-01182, 2134265-2011-01249, 2134265-2011-01250. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND STENTING TREATMENT PROCEDURE, A VESSEL DISSECTION OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE LEFT RENAL ARTERY. A 6F MACH1 GUIDE CATHETER WAS ADVANCED OVER ANOTHER MANUFACTURERS' .035" GUIDE WIRE ENGAGING THE LEFT RENAL ARTERY. THE GUIDE WIRE WAS REMOVED AND EXCHANGED FOR A 190CM THRUWAY GUIDE WIRE; HOWEVER, THIS GUIDE WIRE WAS UNABLE TO CROSS THE LESION. A 300CM JOURNEY GUIDE WAS THEN SELECTED AND CROSSED THE LESION INTO THE DISTAL VESSEL AFTER MULTIPLE ATTEMPTS. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A 4.0 X 15/80 (4F) STERLING BALLOON CATHETER; HOWEVER, THIS WAS UNABLE TO CROSS THE LESION. ANGIOGRAPHY WAS THEN PERFORMED WHICH SHOWED THERE WAS NO FLOW IN THE LEFT RENAL ARTERY INDICATING A DISSECTION IN THE PROXIMAL LEFT RENAL. A 2.5MM X 20MM X 143CM STERLING ES BALLOON CATHETER WAS ADVANCED INTO THE LEFT RENAL AND TWO INFLATIONS WERE PERFORMED. THE BALLOON CATHETER WAS REMOVED AND ANGIOGRAPHY SHOWED THAT FLOW HAD BEEN RESTORED TO THE LEFT RENAL ARTERY. A 4.0X19X150CM EXPRESS SD STENT AND A 5.0X19X150CM EXPRESS SD STENT WERE PLACED IN THE LEFT RENAL ARTERY TO TREAT THE DISSECTION AND COVER THE TARGET LESION. THE 4.0 X 15/80 (4F) STERLING BALLOON CATHETER WAS THEN USED FOR STENT POST-DILATION. ANGIOGRAPHY SHOWED THAT A SMALL DISSECTION STILL EXISTED DISTAL TO THE STENTS; HOWEVER, THIS WAS NON-FLOW LIMITING THEREFORE NO ACTION WAS TAKEN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MACH1 GUIDE CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE M001196620 0050577840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 300CM JOURNEY STR GUIDE WIRE| .035" NON-BSC J-WIRE| .018" 190CM THRUWAY GUIDE WIRE| 4.0 X 15/80 (4F) STERLING BALLOON CATHETER