BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2834442 · Received November 15, 2012

    Report

    Report Number
    2024168-2012-07226
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 21, 2012
    Report Date
    October 22, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DIFFICULTY TO POSITION OR DIFFICULTY TO REMOVE COULD NOT BE CONFIRMED. BASED ON VISUAL AND DIMENSIONAL 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 WOULD 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE MENTIONED IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. THE DEVICE HAS BEEN RECEIVED. THE DEVICE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL FILED REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: REPORTEDLY, THE BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE WAS NOT FLUSHED OR WIPED PRIOR TO USE. THE DIFFICULTY WITH ADVANCEMENT AND RETRACTION OF THE 4.0X8 NC TREK BALLOON DILATATION CATHETER (BDC) OVER THE BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE WAS NOT DUE TO THE COMPLEXITY OF THE PROCEDURE OR DUE TO TORTUOSITY. THE RESISTANCE BETWEEN THESE DEVICES WAS FELT AT THE DISTAL AREA OF THE GUIDE WIRE; THE BMW FEELS "STICKY" AND BECOMES STUCK INSIDE OF THE BDC. REPORTEDLY, IT TOOK 2 TO 3 ATTEMPTS TO ADVANCE THE BDC OVER THE BMW. (B)(4). NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL INTERVENTION PROCEDURE, AFTER ADVANCING AND POSITIONING A BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE TO A LESION IN AN UNSPECIFIED CORONARY VESSEL, AN ATTEMPT WAS MADE TO ADVANCE A 4.0X8 NC TREK RX BALLOON DILATATION CATHETER OVER THE BMW, HOWEVER, THE TREK WAS UNABLE TO BE ADVANCED ON THE BMW. BOTH THE TREK AND THE BMW WERE REMOVED FROM THE ANATOMY AS A SINGLE UNIT. THE PROCEDURE WAS COMPLETED USING A NEW TREK AND A NEW BMW. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. 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 1121761

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: BALANCE MIDDLEWEIGHT UNIVERSAL II