BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2819495 · Received November 5, 2012

    Report

    Report Number
    2024168-2012-06959
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 11, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A STILL FRAME IMAGE WAS RETURNED AND THERE WAS A SLIGHT SHORTNESS ON ONE EDGE APPEARING TO BE 1 MM; HOWEVER, BASED ON THE MANUFACTURING SPECIFICATIONS OF THE PRODUCTS, THIS DOES NOT INDICATE A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THE LOT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER CROSSING THE LESION WITH A BMW ELITE GUIDE WIRE, PRE-DILATATION WAS PERFORMED FIRST WITH A 1.2 X 15 TREK BALLOON, FOLLOWED BY NUMEROUS INFLATIONS WITH A 2.5 X 15 MM TREK BALLOON TO RESTORE SOME FLOW. THE LAD BRANCHED OUT INTO SEPTAL AND DIAGONAL, WITH SEPTAL REACHING THE APEX. THE 2.5 X 18 MM ABSORB SCAFFOLD WAS IMPLANTED AT 12 ATMOSPHERES (ATM) IN THE PROXIMAL LAD, COVERING BEFORE THE BRANCH. THE 2.75 X 15 MM VOYAGER NC BALLOON WAS ADVANCED WITHOUT RESISTANCE FOR POST-DILATATION, BUT THE LENGTH OF THE BALLOON APPEARED TO BE LONGER THAN THE IMPLANTED 2.5 X 18 MM ABSORB SCAFFOLD AT FREEZE FRAME AND 2X MAG STENT BOOST. THE BALLOON WAS EXCHANGED FOR A 2.75 X 12 MM VOYAGER NC, WHICH APPEARED TO BE MARGINALLY SHORTER THAN 18 MM SCAFFOLD. POST-DILATATION WAS PERFORMED AT 18 ATM AND WAS ANGIOGRAPHICALLY SUCCESSFUL. THE PHYSICIAN COMMENTED THAT HE FOUND IT VERY STRANGE THAT THE VOYAGER NC 15 MM IS LONGER THAN ABSORB 18MM; HOWEVER, THIS OBSERVATION WAS NOT RECORDED IN CINE. THE SAME VOYAGER NC WAS USED, WITHOUT ISSUE, FOR POST-DILATATION OF TWO OVERLAPPING 18 MM STENTS IN THE CIRCUMFLEX. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2030661

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: BMW ELITEOTHER: 2.5X18MM ABSORB