BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2173372 · Received July 23, 2011

    Report

    Report Number
    2024168-2011-05092
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 24, 2011
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED NC TREK RX DILATATION CATHETER CONFIRMED THE REPORTED RUPTURE WHICH WAS LIKELY A RESULT OF AN INTERACTION WITH THE MODERATELY CALCIFIED LESION. THE FAILURE TO SOAK THE BALLOON PRIOR TO USE MAY ALSO HAVE CONTRIBUTED TO THE RUPTURE. ADDITIONALLY, RETURN ANALYSIS NOTED THE HYPOTUBE WAS SEPARATED; HOWEVER, FOLLOW UP INFORMATION RECEIVED FROM THE ACCOUNT CONFIRMED THE SEPARATION DID NOT OCCUR DURING THE PROCEDURE AND LIKELY WAS A RESULT OF HANDLING DURING PACKING FOR RETURN. REVIEW OF THE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS FOR THE LOT INDICATING ALL LOT RELEASE TESTING MET SPECIFICATION. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED NO SIMILAR INCIDENTS REPORTED FOR INFLATION ISSUES OR BALLOON RUPTURE. BASED ON THIS INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MODERATELY CALCIFIED, DE NOVO, PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, THE NC TREK BALLOON LEAKED DURING THE FIRST INFLATION ATTEMPT AND COULD NOT BE INFLATED. THERE WAS NO REPORTED ADVERSE CONSEQUENCE TO THE PATIENT. IT WAS FURTHER REPORTED THAT ALTHOUGH THE CATHETER WAS FLUSHED, THE BALLOON WAS NOT SUBMERGED IN SALINE DURING PREPARATION. A SECOND TREK WAS USED IN THE PROCEDURE WITHOUT INCIDENT. THOUGH REQUESTED, 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 1010461

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: BMW UNIVERSAL II