BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENKU DILATATION CATHETER

    MDR report key: 2931715 · Received January 28, 2013

    Report

    Report Number
    2024168-2013-00431
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    December 29, 2012
    Report Date
    January 4, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: GUIDE WIRE: RUNTHROUGH HC, GUIDE CATH: BRIGHT TIP JR4.0 6F. THE TENKU BALLOON DILATION CATHETER DEVICE IS AN ABBOTT VASCULAR MANUFACTURED DEVICE WHICH IS DISTRIBUTED IN (B)(4). THOUGH THIS DEVICE IS NOT COMMERCIALLY AVAILABLE FOR SALE IN THE US, IT IS SIMILAR TO A DEVICE CURRENTLY MARKETED FOR SALE IN THE US. BRAND NAME AND G5/PMA/510K # OF THIS MEDWATCH CORRESPOND TO THE DEVICE CURRENTLY MARKETED FOR SALE IN THE US. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED INFLATION ISSUE COULD NOT BE CONFIRMED. BASED ON ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TOTALLY OCCLUDED LESION IN MID RIGHT CORONARY ARTERY IN AN ACUTE MYOCARDIAL INFARCTION PATIENT. THE 2.0 X 20 MM TENKU BALLOON CATHETER WAS PREPARED PER THE INSTRUCTIONS FOR USE AND ADVANCED WITHOUT ISSUE FOR PRE-DILATATION. THE BALLOON WAS INFLATED TO 10 ATMOSPHERES (ATM); HOWEVER, THE BALLOON DID NOT APPEAR TO INFLATE ON ANGIOGRAPHY. ANOTHER ATTEMPT WAS MADE TO INFLATE THE BALLOON TO 10 ATM, BUT WAS UNSUCCESSFUL. THE BALLOON CATHETER WAS REMOVED EASILY. AFTER THE WITHDRAWAL FROM THE PATIENT ANATOMY, THE BALLOON CATHETER WAS PRESSURIZED AND INFLATED WITHOUT ISSUE. THE PHYSICIAN HAD NO IDEA WHY THE BALLOON WOULD NOT BE INFLATED IN THE PATIENT ANATOMY. A NON-ABBOTT BALLOON WAS USED AND A PROMUS WAS DEPLOYED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37234 TENKU DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20807G1

    Patients

    Seq Age Sex Outcome Treatment
    1