BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK¿ PLUS

    MDR report key: 2880277 · Received December 19, 2012

    Report

    Report Number
    2134265-2012-07951
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 27, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. 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).

    Description of Event or Problem · 1

    SAME CASE AS: MDR ID 2134265-2012-07782. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE TIP SEPARATION OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOLLOWING THE THIRD RUN OF ABLATION AT A SPEED OF UP TO 210,000RPM, THE PHYSICIAN ATTEMPTED TO WITHDRAW THE 1.50MM ROTABLATOR ROTALINK PLUS BURR, HOWEVER, HE DID NOT ACTIVATE THE DYNAGLIDE MODE. LATER, IT WAS OBSERVED THAT A 1.3MM RADIOPAQUE SECTION OF THE GUIDE WIRE HAD SEPARATED AT THE DISTAL END IN THE LAD. THE FRAGMENTED PIECE WAS LEFT IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT FOUR RUNS OF ABLATION WERE PERFORMED ON THE PROGRESSIVE TARGET LESION FOR 13SECS, 12SECS, 10SECS AND 7SECS EACH. NO ATTEMPTS WERE MADE TO RETRIEVE THE GUIDE WIRE FRAGMENT. THE PHYSICIAN DILATED THE LESION WITH A NC QUANTUM BALLOON CATHETER AND DEPLOYED PROMUS ELEMENT 3.0X28MM AND PROMUS ELEMENT 2.5X38MM AND PERFORMED IVUS AFTER THE STENTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTALINK¿ PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 7FR MACH 1 CLS 3.5SH