BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRODUCER SHEATH

    MDR report key: 6446394 · Received March 30, 2017

    Report

    Report Number
    1220452-2017-00024
    Event Type
    Malfunction
    Date Received
    March 30, 2017
    Date of Event
    February 1, 2016
    Report Date
    May 31, 2017
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DTB
    PMA / PMN Number
    K791963
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    AUTHORS: RAMANAND PRASAD SINHA, SHIVANI RAKESH KOTHARI, AS HOK SURYAKANT THAKKAR. JOURNAL: JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH. YEAR AND ISSUE: 2016 FEB, VOL-10(2): OD14-OD15. TITLE: NECESSITY IS THE MOTHER OF INVENTION. REF: DOI: 10.7860/JCDR/2016/14926.7232. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT WAS TAKEN FOR ELECTIVE PTMV BY INOUE BALLOON. THE TRANSSEPTAL PUNCTURE WAS MADE USING BROCKENBROUGH CURVED NEEDLE THROUGH 8-FR MULLINS DILATOR. THE NEEDLE ENTRY INTO LEFT ATRIUM (LA) WAS CONFIRMED BY MEASURING LA PRESSURE AND BY CONTRAST INJECTION. FOLLOWING CONFIRMATION, EFFORTS WERE MADE TO ADVANCE MULLINS SHEATH DILATOR OVER NEEDLE, BUT THE DILATOR DID NOT ADVANCE OVER THE NEEDLE. RAO PROJECTION VIEW REVEALED THAT NEEDLE CAME OUT OF THE MULLINS DILATOR, NOT FROM THE TIP OF DILATOR BUT FROM A PUNCTURE POINT BEFORE THE TIP OF DILATOR. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE WITH SAME NEEDLE AND DILATOR, BUT EVERY TIME THE NEEDLE PROTRUDED OUT FROM THE SAME PUNCTURE POINT. THE WHOLE TRANSSEPTAL SYSTEM WAS REMOVED FROM THE BODY AND IT WAS FOUND THAT MULLINS DILATOR SHAFT HAD A LARGE HOLE BEFORE THE TIP OF DILATOR. BPN NEEDLE IS A SHARP NEEDLE AND AT THE TIME OF ADVANCEMENT VIA SHEATH DILATOR, IT¿S TIP DID NOT REMAIN COAXIAL DUE TO BEND AT IVC AND RA JUNCTION AND HIT THE LATERAL WALL OF SHEATH AND AS A RESULT A HOLE WAS CREATED DURING THE PROCEDURE. TIP OF THE DILATOR WAS CUT UP TO THE HOLE OF DILATOR AND MADE BLUNT. AGAIN TRANSSEPTAL PUNCTURE WAS MADE AND NEEDLE ENTERED LA BUT DILATOR HAD A PROBLEM IN ADVANCING OVER THE NEEDLE DUE TO ITS BLUNT TIP. THEN 0.0014-INCH ANGIOPLASTY NON MEDTRONIC BMW GUIDE WIRE WAS ADVANCED THROUGH THE NEEDLE INTO LEFT ATRIUM AND WAS STABILIZED IN LEFT SUPERIOR PULMONARY VEIN. ANGIOPLASTY WIRE WAS LEFT IN THE LEFT ATRIUM AND WHOLE SYSTEM OF TRANSSEPTAL NEEDLE AND MULLINS DILATOR WAS REMOVED. A 3 × 20 MM NONCOMPLIANT CORONARY BALLOON WAS PLACED OVER ANGIOPLASTY WIRE ACROSS INTER ATRIAL SEPTUM AND DILATED AT 24 MM HG. FOLLOWED BY BALLOON DILATIONS, SEPTAL DILATOR WAS USED OVER ANGIOPLASTY WIRE FOR SEPTAL DILATION. KEEPING SEPTAL DILATOR ACROSS SEPTUM WITH TIP IN LA, ANGIOPLASTY WIRE WAS REMOVED AND LA WIRE WAS PASSED THROUGH SEPTAL DILATOR. THE REMAINING PROCEDURE EVENTUATED AS THE USUAL BALLOON VALVOTOMY METHODS. POST PROCEDURE ECHO REVEALED MILD MITRAL REGURGITATION AND MEAN GRADIENT ACROSS MITRAL VALVE TO BE 8 MM HG. PATIENT WAS DISCHARGED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230016 INTRODUCER SHEATH ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR