BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MONORAIL

    MDR report key: 1760054 · Received July 16, 2010

    Report

    Report Number
    2134265-2010-03104
    Event Type
    Injury
    Date Received
    July 16, 2010
    Date of Event
    June 21, 2010
    Report Date
    June 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 80% STENOSED DE NOVO ECCENTRIC LESION MEASURING 3.0MM IN DIAMETER AND 25MM IN LENGTH WAS LOCATED IN A MODERATELY CALCIFIED DISTAL FEMORAL ARTERY THAT WAS SEVERELY TORTUOUS IN THE VESSEL PROXIMAL TO THE LESION. THE LESION WAS PREDILATED WITH A 2MM X 3CM ULTRA-THIN DIAMOND BALLOON. THE LESION WAS FURTHER TREATED WITH A NON BSC ATHERECTOMY DEVICE. A 3.0X30MM APEX BALLOON WAS THEN ADVANCED TO THE LESION TO PREDILATE PRIOR TO STENTING. THE PHYSICIAN WAS ATTEMPTING TO ADVANCE THE DEVICE OVER A NON BSC GUIDE WIRE THAT WAS KINKED AND RESISTANCE WAS FELT AT THE ILIAC BIFURCATION AND ALSO WHILE ATTEMPTING TO CROSS THE LESION. THE DEVICE SHAFT FRACTURED AT THE LOCATION OF THE MONORAIL PORT AND THE DEVICE WAS REMOVED WITH A SNARE. THE PROCEDURE WAS COMPLETED BY STENTING WITH BOTH A 6MM X 4CM SENTINOL STENT AND A 7MM X 39MM SENTINOL STENT. THE STENTS WERE THEN POST-DILATED WITH A 5MM X 6CM ULTRA-THIN DIAMOND BALLOON AND A 5.0X20MM NC QUANTUM APEX BALLOON. NO PATIENT COMPLICATIONS OCCURRED. PATIENT CONDITION IS LISTED AS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 80% STENOSED DE NOVO ECCENTRIC LESION MEASURING 3.0MM IN DIAMETER AND 25MM IN LENGTH WAS LOCATED IN A MODERATELY CALCIFIED DISTAL FEMORAL ARTERY THAT WAS SEVERELY TORTUOUS IN THE VESSEL PROXIMAL TO THE LESION. THE LESION WAS PREDILATED WITH A 2MM X 3CM ULTRA-THIN DIAMOND BALLOON. THE LESION WAS FURTHER TREATED WITH A NON BSC ATHERECTOMY DEVICE. A 3.0X30MM APEX BALLOON WAS THEN ADVANCED TO THE LESION TO PREDILATE PRIOR TO STENTING. THE PHYSICIAN WAS ATTEMPTING TO ADVANCE THE DEVICE OVER A NON BSC GUIDE WIRE THAT WAS KINKED AND RESISTANCE WAS FELT AT THE ILIAC BIFURCATION AND ALSO WHILE ATTEMPTING TO CROSS THE LESION. THE DEVICE SHAFT FRACTURED AT THE LOCATION OF THE MONORAIL PORT AND THE DEVICE WAS REMOVED WITH A SNARE. THE PROCEDURE WAS COMPLETED BY STENTING WITH BOTH A 6MM X 4CM SENTINOL STENT AND A 7MM X 39MM SENTINOL STENT. THE STENTS WERE THEN POST-DILATED WITH A 5MM X 6CM ULTRA-THIN DIAMOND BALLOON AND A 5.0X20MM NC QUANTUM APEX BALLOON. NO PATIENT COMPLICATIONS OCCURRED. PATIENT CONDITION IS LISTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493895930300 0013178420

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention 3MM X 2CM ULTRA-THIN DIAMOND BALLOON| 7FR CROSSOVER GUIDE CATHETER| 0.014 - 335CM VIPERWIRE ADVANCE GUIDE WIRE| DIAMONDBACK ATHERECTOMY CATHETER