BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT 2 (TM)

    MDR report key: 2201915 · Received August 11, 2011

    Report

    Report Number
    2134265-2011-03221
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR. DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED THE DEVICE IS FRACTURED 182.3CM FROM THE PROXIMAL END. ALL OUTER DIAMETER MEASUREMENTS WERE WITHIN SPECIFICATIONS. SEM LAB ANALYSIS CONCLUDED THE FAILURE OCCURRED DUE TO A TENSION OVERLOAD. 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A GUIDE WIRE TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH ACUTE ANTERIOR WALL INFARCTION WITH SYMPTOMS BEGINNING 2-3 DAYS PRIOR TO THE PROCEDURE. ANGIOGRAPHY REVEALED A 90% STENOSED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH "BRIGHTENED LARGE PROXIMAL PLAQUE RUPTURE" AND TIMI 2 FLOW. IN THE AREA OF THE LAD FROM THE MAIN STEM, A TRIFURCATION WAS IDENTIFIED WITH A LARGE RAMUS INTERMEDIUS AND LARGE CIRCUMFLEX RAMUS WITH LEFT DOMINANT CORONARY CIRCULATION. AS SIGNIFICANT THROMBOSIS WAS PRESENT, INTRAVENOUS MEDICATION WAS ADMINISTERED AND ASPIRATION AND LYSIS WERE PERFORMED. AS THE LESION WAS LOCATED IN THE "EXTREME" PROXIMAL LAD, THE PHYSICIAN OPTED TO PLACE GUIDE WIRES IN BOTH THE RAMUS INTERMEDIUS AND THE CIRCUMFLEX RAMUS. NO RESISTANCE WAS NOTED WHILE ADVANCING THE CHOICE PT2 GUIDE WIRE TO THE RAMUS INTERMEDIUS. HOWEVER, WHEN PLACING THE DEVICE, THE TIP OF THE WIRE FLIPPED OVER AND WAS PLACED DISTALLY IN THE FORM OF A "J". THE WIRE WAS HELD IN PLACE WITH A TROCAR TO AVOID FURTHER MOVEMENT. A NON BSC GUIDE WIRE WAS PLACED IN THE CIRCUMFLEX RAMUS AND ALSO SECURED WITH A TROCAR. A SECOND CHOICE PT2 WAS ADVANCED AND UTILIZED DURING THE INTERVENTION OF THE LAD WHICH INCLUDED ANGIOPLASTY AND STENT IMPLANTATION. THIS PORTION OF THE PROCEDURE WAS MAINLY PERFORMED UNDER "INSERTED COLLIMATOR". NEAR THE END OF THE PROCEDURE, THEY CHANGED TO A FULL VIEW WHICH REVEALED TWO WIRE FRAGMENTS, APPROXIMATELY 8 AND 14MM LONG, IN THE DISTAL RAMUS INTERMEDIUS. THE PHYSICIAN NOTED THAT THE PATIENT IS "VERY SPORITV AND HAS A VERY HIGH MUSCLE ACTIVITY, POSSIBLY THE WIRE WAS RHYTHMICALLY PRESSED TOGETHER IN THE LOOP AND A PREDETERMINED BREAKING POINT ACCURED". THE PROCEDURE WAS ENDED AT THIS POINT. THE PHYSICIAN HAS NOT YET DETERMINED IF THE WIRE FRAGMENTS WILL BE LEFT OR IF FURTHER INTERVENTION WILL BE NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A GUIDE WIRE TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH ACUTE ANTERIOR WALL INFARCTION WITH SYMPTOMS BEGINNING 2-3 DAYS PRIOR TO THE PROCEDURE. ANGIOGRAPHY REVEALED A 90% STENOSED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH "BRIGHTENED LARGE PROXIMAL PLAQUE RUPTURE" AND TIMI 2 FLOW. IN THE AREA OF THE LAD FROM THE MAIN STEM, A TRIFURCATION WAS IDENTIFIED WITH A LARGE RAMUS INTERMEDIUS AND LARGE CIRCUMFLEX RAMUS WITH LEFT DOMINANT CORONARY CIRCULATION. AS SIGNIFICANT THROMBOSIS WAS PRESENT, INTRAVENOUS MEDICATION WAS ADMINISTERED AND ASPIRATION AND LYSIS WERE PERFORMED. AS THE LESION WAS LOCATED IN THE "EXTREME" PROXIMAL LAD, THE PHYSICIAN OPTED TO PLACE GUIDE WIRES IN BOTH THE RAMUS INTERMEDIUS AND THE CIRCUMFLEX RAMUS. NO RESISTANCE WAS NOTED WHILE ADVANCING THE CHOICE PT2 GUIDE WIRE TO THE RAMUS INTERMEDIUS. HOWEVER, WHEN PLACING THE DEVICE, THE TIP OF THE WIRE FLIPPED OVER AND WAS PLACED DISTALLY IN THE FORM OF A "J." THE WIRE WAS HELD IN PLACE WITH A TROCAR TO AVOID FURTHER MOVEMENT. A NON BSC GUIDE WIRE WAS PLACED IN THE CIRCUMFLEX RAMUS AND ALSO SECURED WITH A TROCAR. A SECOND CHOICE PT2 WAS ADVANCED AND UTILIZED DURING THE INTERVENTION OF THE LAD WHICH INCLUDED ANGIOPLASTY AND STENT IMPLANTATION. THIS PORTION OF THE PROCEDURE WAS MAINLY PERFORMED UNDER "INSERTED COLLIMATOR." NEAR THE END OF THE PROCEDURE, THEY CHANGED TO A FULL VIEW WHICH REVEALED TWO WIRE FRAGMENTS, APPROXIMATELY 8 AND 14MM LONG, IN THE DISTAL RAMUS INTERMEDIUS. THE PHYSICIAN NOTED THAT THE PATIENT IS "VERY SPORTIVE AND HAS A VERY HIGH MUSCLE ACTIVITY, POSSIBLY THE WIRE WAS RHYTHMICALLY PRESSED TOGETHER IN THE LOOP AND A PREDETERMINED BREAKING POINT OCCURRED." THE PROCEDURE WAS ENDED AT THIS POINT. THE PHYSICIAN HAS NOT YET DETERMINED IF THE WIRE FRAGMENTS WILL BE LEFT OR IF FURTHER INTERVENTION WILL BE NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT 2 (TM) WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA H74938931030

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other