BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2882680 · Received December 20, 2012

    Report

    Report Number
    2024168-2012-08235
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    October 18, 2012
    Report Date
    November 29, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    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 REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE IS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MILDLY TORTUOUS, MILDLY CALCIFIED, RIGHT CORONARY ARTERY (RCA) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE, DURING POST-DILATATION, A NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION, BUT THERE WAS DIFFICULTY IN POST-DILATATION AND THE BALLOON SLIPPED OFF THE LESION AND THERE WAS DIFFICULTY WITH PLACING THE BALLOON BACK OVER THE LESION. THERE WAS A SUCCESSFUL PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE OF THE RCA. THERE WAS NO ADVERSE PATIENT EFFECT OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MILDLY TORTUOUS, MILDLY CALCIFIED, RIGHT CORONARY ARTERY (RCA) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE, AFTER AN ABSORB STENT WAS IMPLANTED WITHOUT DIFFICULTY, A NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO A NEW LESION FOR PRE-DILATATION, BUT THE BALLOON SLIPPED OFF THE LESION AND THERE WAS DIFFICULTY WITH PLACING THE BALLOON BACK OVER THE LESION. THE NC TREK BDC WAS REMOVED AND THE PROCEDURE WAS ABANDONED. THERE WAS NO ADVERSE PATIENT EFFECT OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2051661

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR