BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2230144 · Received August 31, 2011

    Report

    Report Number
    2024168-2011-06059
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    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. GUIDE WIRE: SION BLUE. GUIDE CATH: TAIGA JL4.0. POTENTIAL FACTORS THAT MAY CONTRIBUTE TO DIFFICULTY INFLATING AND/OR WATERMELON SEEDING MAY INCLUDE, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, DEVICE SIZE SELECTION, PLACEMENT OF THE BALLOON WITHIN THE LESION, OR PHYSICIAN TECHNIQUE. TO HELP ENSURE THIS IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, VARIOUS QUALITY CHECKS ARE IN PLACE TO VERIFY VISUAL, FUNCTIONAL AND DIMENSIONAL SPECIFICATIONS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER BALLOON INFLATION. RETURN OF THE NC TREK CATHETER MAY HAVE AIDED IN THE INVESTIGATION AS WITHOUT THE CATHETER TO EXAMINE A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. A SEARCH OF THE LOT HISTORY RECORD INDICATED NO NON-CONFORMING MATERIAL RECORDS FOR THE LOT. ADDITIONALLY A QUERY OF THE COMPLAINT HANDLING DATABASE INDICATED NO OTHER INCIDENTS. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. BASED ON THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE VESSEL HAD NO TORTUOSITY, NO CALCIFICATION, WAS A CONCENTRIC LESION WITH INSTENT RESTENOSIS (ISR) OF A NON ABBOTT STENT. THE TARGET VESSEL DIAMETER WAS 3.75 MM AND THE TARGET VESSEL LENGTH WAS 15 MM. THE GUIDE WIRE WAS DELIVERED TOWARD THE LAD, AND DILATATION WAS PERFORMED AT THE LOCATION OF THE ISR IN THE TARGET LESION WITH THE 4.0X8 MM NC TREK DILATATION BALLOON; HOWEVER, DURING INFLATION TO 4 ATMOSPHERES, THE BALLOON SLIPPED AND MOVED DURING DILATATION. AFTER FIVE ATTEMPTS WERE MADE TO INFLATE THE BALLOON, THE BALLOON CATHETER WAS EXCHANGED FOR A NON-ABBOTT DILATATION BALLOON AND THE PROCEDURE WAS COMPLETED, WITH NO ADVERSE EFFECTS TO THE PATIENT. NO ADDITIONAL INFORMATION WAS 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 1040461

    Patients

    Seq Age Sex Outcome Treatment
    1