BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2032838 · Received March 29, 2011

    Report

    Report Number
    2134265-2011-01145
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: ONE DEVICE WAS RECEIVED WITH THE DISTAL TIP FRACTURED. THE VISUAL AND TACTILE INSPECTION WAS PERFORMED AND THE DEVICE PRESENTS WITH A CORE WIRE FRACTURE AT 298.7CM FROM THE PROXIMAL END. ALL THE OUTER DIAMETER MEASUREMENTS ARE WITHIN THE SPECIFICATIONS. THE FRACTURED PORTION WAS SENT TO THE SEM LAB FOR ANALYSIS. RESULTS: THE FRACTURE OCCURRED DUE TO A REDUCTION IN THE CROSS-SECTIONAL AREA OF THE WIRE IN A BENDING OVERLOAD DIRECTION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2011-01146. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A WIRE FRACTURE OCCURRED. THE 20MM LONG, 99% STENOSED GREATER THAN 45 DEGREE ANGLED LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS DISTAL LEFT CIRCUMFLEX ARTERY (LCX). FOLLOWING PLACEMENT OF THE FLOPPY ROTAWIRE GUIDE WIRE, THE PHYSICIAN ABLATED THE LESION WITH THE ROTABLATOR ROTALINK PLUS 1.25MM BURR, HOWEVER THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE BURR DID NOT CROSS THE LEISON. THE PHYSICIAN THEN NOTED THE GUIDE WIRE TO BE FRACTURED WITH ONE FRAGMENT REMAINING IN THE POSTEROLATERAL LCX AND THE SECOND FRAGMENT IN THE POSTERIOR DESCENDING LCX. NO RETRIEVAL OF THE FRAGMENTS WAS ATTEMPTED, HOWEVER THE PHYSICIAN PLACED COILS TO SECURE THE WIRE FRAGMENTS. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. NO FURTHER COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2011-01146. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A WIRE FRACTURE OCCURRED. THE 20MM LONG, 99% STENOSED GREATER THAN 45 DEGREE ANGLED LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS DISTAL LEFT CIRCUMFLEX ARTERY (LCX). FOLLOWING PLACEMENT OF THE FLOPPY ROTAWIRE GUIDE WIRE, THE PHYSICIAN ABLATED THE LESION WITH THE ROTABLATOR ROTALINK PLUS 1.25MM BURR, HOWEVER THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE BURR DID NOT CROSS THE LESION. THE PHYSICIAN THEN NOTED THE GUIDE WIRE TO BE FRACTURED WITH ONE FRAGMENT REMAINING IN THE POSTEROLATERAL LCX AND THE SECOND FRAGMENT IN THE POSTERIOR DESCENDING LCX. NO RETRIEVAL OF THE FRAGMENTS WAS ATTEMPTED, HOWEVER THE PHYSICIAN PLACED COILS TO SECURE THE WIRE FRAGMENTS. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. NO FURTHER COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA H802228240020 13643282

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ROTABLATOR ROTALINK PLUS 1.25MM