BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK? BURR

    MDR report key: 3030515 · Received April 2, 2013

    Report

    Report Number
    2134265-2013-01896
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED THAT THE ROTABLATOR CATHETER UNIT WAS NOTE RETURNED; ONLY THE BURR WAS RETURNED DETACHED FROM THE COIL AND REMAINING CATHETER BODY WITH A SECTION OF COIL STILL ATTACHED TO THE BURR. THE BURR WAS MICROSCOPICALLY EXAMINED AND THE ANNULUS WAS FLARED AND DAMAGED. THE REMAINING COIL ATTACHED TO THE BURR WAS MICROSCOPICALLY EXAMINED AND WAS NOT FOUND TO BE STRETCHED. 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).

    Description of Event or Problem · 1

    SAME CASE AS MFR: 2134265-2013-01900. IT WAS REPORTED THAT DURING A PERCUTANEOUS ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE BURR BECAME STUCK IN THE LESION. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 85% STENOSED, ECCENTRIC SHAPED, DE NOVO LESION TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED, 3.5MM IN DIAMETER LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS PRE-DILATED WITH AN UNSPECIFIED 3.0X18MM BALLOON CATHETER. A 1.50MM ROTALINK BURR AND ROTALINK ADVANCER WERE SELECTED AND SUCCESSFULLY CROSSED THE LESION BUT DID NOT DILATE THE CHAMBER. THE PHYSICIAN CHANGED TO A 1.75MM ROTALINK BURR AND SUCCESSFULLY CROSSED THE LESION ON THE FIRST ABLATION. ON THE SECOND ABLATION WHEN THE ROTAKINK BURR REACHED THE LESION, THE ROTALINK BURR BECAME STUCK IN THE DISTAL PORTION OF THE LESION AND COULD NOT BE WITHDRAWN. DURING THE PROCEDURE, THE ADVANCER HAD MADE AN ABNORMAL SOUND. IT WAS NOTED THAT THE ROTALINK ADVANCER AND 1.5MM ROTALINK BURR WERE TESTED OUTSIDE THE PATIENT AND DID NOT MAKE ANY ABNORMAL SOUNDS. THE PHYSICIAN TRIED TO WITHDRAW THE ROTALINK BURR SEVERAL TIMES BUT FAILED AND DECIDED TO SURGICALLY REMOVE THE DEVICE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    SAME CASE AS MFR: 2134265-2013-01900. IT WAS REPORTED THAT DURING A PERCUTANEOUS ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE BURR BECAME STUCK IN THE LESION. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 85% STENOSED, ECCENTRIC SHAPED, DE NOVO LESION TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED, 3.5MM IN DIAMETER LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS PRE-DILATED WITH AN UNSPECIFIED 3.0X18MM BALLOON CATHETER. A 1.50MM ROTALINK BURR AND ROTALINK ADVANCER WERE SELECTED AND SUCCESSFULLY CROSSED THE LESION BUT DID NOT DILATE THE CHAMBER. THE PHYSICIAN CHANGED TO A 1.75MM ROTALINK BURR AND SUCCESSFULLY CROSSED THE LESION ON THE FIRST ABLATION. ON THE SECOND ABLATION WHEN THE ROTAKINK BURR REACHED THE LESION, THE ROTALINK BURR BECAME STUCK IN THE DISTAL PORTION OF THE LESION AND COULD NOT BE WITHDRAWN. DURING THE PROCEDURE, THE ADVANCER HAD MADE AN ABNORMAL SOUND. IT WAS NOTED THAT THE ROTALINK ADVANCER AND 1.5MM ROTALINK BURR WERE TESTED OUTSIDE THE PATIENT AND DID NOT MAKE ANY ABNORMAL SOUNDS. THE PHYSICIAN TRIED TO WITHDRAW THE ROTALINK BURR SEVERAL TIMES BUT FAILED AND DECIDED TO SURGICALLY REMOVE THE DEVICE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135005 ROTALINK? BURR CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H802227680040 15090761

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention BALLOON CATHETER: 3.0.18| GUIDE CATHETER: LAUNCHER EBU3.5