BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK? PLUS

    MDR report key: 3180436 · Received June 20, 2013

    Report

    Report Number
    2134265-2013-04290
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE BURR WAS MICROSCOPICALLY EXAMINED. THE ANNULUS WAS FOUND TO BE FLARED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-04289, 2134265-2013-04291. IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, THE WIRE WAS DETACHED/SEPARATED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL (LAD) LEFT ANTERIOR DESCENDING. A ROTAWIRE EX SUPPORT GUIDEWIRE WAS SELECTED TO GUIDE THE BURR. IT WAS NOTED THAT ABLATION WAS PERFORMED AT LEFT CIRCUMFLEX ARTERY AND POST DILATATION WAS PERFORMED USING A NON-BSC BALLOON CATHETER AND THEN A PROMUS ELEMENT PLUS STENT 3.0 X 20 WAS DEPLOYED. THEN THE ROTAWIRE WAS ADVANCED BETWEEN THE LAD AND AT THE FIRST DIAGONAL BRANCH, AND ABLATION WAS PERFORMED AT OSTIAL PART OF LAD. WHEN ATTEMPTING TO PERFORM 3RD ABLATION THE ROTAWIRE WAS DETACHED. THE DETACHED WIRE WAS REMOVED USING A NON-BSC DEVICE. AFTER REMOVING THE DETACHED WIRE ANOTHER ABLATION WAS PERFORMED USING A ROTABURR 1.5 AND ANOTHER ROTAWIRE EX SUPPORT GUIDEWIRE. UPON 4TH ABLATION, IT WAS THEN NOTED THAT ANOTHER ROTAWIRE WAS DETACHED AT FIRST DIAGONAL BRANCH. THE DETACHED WIRE WAS NOT REMOVED FROM THE PATIENT¿S BODY. POST DILATATION WAS PERFORMED USING A NON-BSC PRODUCT AT THE OSTIAL PART OF THE FIRST DIAGONAL BRANCH THEN ABLATION WAS DISCONTINUED. SAME PROCEDURE WAS PERFORMED TO LAD. POST DILATATION WAS PERFORMED AT THE MIDDLE AND PROXIMAL LAD USING A DIFFERENT NON-BSC BALLOON CATHETER. A PROMUS ELEMENT PLUS STENT 2.5 X 15MM WAS THEN DEPLOYED AT THE MIDDLE LAD WITH A NON-BSC BALLOON CATHETER. A NON-BSC STENT WAS DEPLOYED AT PROXIMAL LAD WITH A NON-BSC BALLOON CATHETER. THEN A KISSING BALLOON TECHNIQUE WAS PERFORMED FOR THE TREATMENT OF THE PROXIMAL LAD AND AT THE FIRST DIAGONAL BRANCH. HUGGING BALLOON TECHNIQUE WAS PERFORMED AND ADDITIONAL DILATATION WAS MADE AT THE PROXIMAL LAD WITH A NON-BSC BALLOON CATHETER. PROCEDURE WAS THEN COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CONDITION WAS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-04289, 2134265-2013-04291. IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, THE WIRE WAS DETACHED/SEPARATED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL (LAD) LEFT ANTERIOR DESCENDING. A ROTAWIRE EX SUPPORT GUIDEWIRE WAS SELECTED TO GUIDE THE BURR. IT WAS NOTED THAT ABLATION WAS PERFORMED AT LEFT CIRCUMFLEX ARTERY AND POST DILATATION WAS PERFORMED USING A NON-BSC BALLOON CATHETER AND THEN A PROMUS ELEMENT PLUS STENT 3.0 X 20 WAS DEPLOYED. THEN THE ROTAWIRE WAS ADVANCED BETWEEN THE LAD AND AT THE FIRST DIAGONAL BRANCH, AND ABLATION WAS PERFORMED AT OSTIAL PART OF LAD. WHEN ATTEMPTING TO PERFORM 3RD ABLATION THE ROTAWIRE WAS DETACHED. THE DETACHED WIRE WAS REMOVED USING A NON-BSC DEVICE. AFTER REMOVING THE DETACHED WIRE ANOTHER ABLATION WAS PERFORMED USING A ROTABURR 1.5 AND ANOTHER ROTAWIRE EX SUPPORT GUIDEWIRE. UPON 4TH ABLATION, IT WAS THEN NOTED THAT ANOTHER ROTAWIRE WAS DETACHED AT FIRST DIAGONAL BRANCH. THE DETACHED WIRE WAS NOT REMOVED FROM THE PATIENT¿S BODY. POST DILATATION WAS PERFORMED USING A NON-BSC PRODUCT AT THE OSTIAL PART OF THE FIRST DIAGONAL BRANCH THEN ABLATION WAS DISCONTINUED. SAME PROCEDURE WAS PERFORMED TO LAD. POST DILATATION WAS PERFORMED AT THE MIDDLE AND PROXIMAL LAD USING A DIFFERENT NON-BSC BALLOON CATHETER. A PROMUS ELEMENT PLUS STENT 2.5 X 15MM WAS THEN DEPLOYED AT THE MIDDLE LAD WITH A NON-BSC BALLOON CATHETER. A NON-BSC STENT WAS DEPLOYED AT PROXIMAL LAD WITH A NON-BSC BALLOON CATHETER. THEN A KISSING BALLOON TECHNIQUE WAS PERFORMED FOR THE TREATMENT OF THE PROXIMAL LAD AND AT THE FIRST DIAGONAL BRANCH. HUGGING BALLOON TECHNIQUE WAS PERFORMED AND ADDITIONAL DILATATION WAS MADE AT THE PROXIMAL LAD WITH A NON-BSC BALLOON CATHETER. PROCEDURE WAS THEN COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280829 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GUIDEWIRE: SION BLUE| STENT: PROMUSELMNET 2.5X28/3.0X20| BALLOON CATHETER: NC TREK| GUIDING CATHETER: LAUNCHER LAUNCHER / EBU3.5SH