BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2063429 · Received April 19, 2011

    Report

    Report Number
    2134265-2011-01250
    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
    K053118
    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. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR #'S: 2134265-2011-01181, 2134265-2011-01182, 2134265-2011-01249. 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 MANUFACTURER'S .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 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031401580 14110452

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention .018" 190CM THRUWAY GUIDE WIRE| .035" NON-BSC J-WIRE| 6F PV MACH1 LIMA GUIDE CATHETER| 300CM JOURNEY STR GUIDE WIRE