BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2132629 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04296
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED NC TREK DILATATION CATHETER NOTED BLOOD VISIBLE IN THE INFLATION LUMEN AND ON THE ENTIRE LENGTH OF THE SHAFT, WHICH IS CONSISTENT WITH THE CATHETER BEING ADVANCED INSIDE THE PATIENT AND A LEAK OR BALLOON RUPTURE. THE BALLOON WAS ALSO FOUND TO BE LOOSELY-FOLDED, WHICH SUGGESTS THAT AT SOME POINT, POSITIVE PRESSURE MAY HAVE BEEN APPLIED TO THE SYSTEM, CAUSING THE BALLOON TO SLIGHTLY EXPAND. ALTHOUGH IT IS NOT KNOWN AT WHAT POINT THE BALLOON HAD BEEN INFLATED, THIS MAY HAVE OCCURRED FROM HANDLING AFTER THE LEAK WAS NOTED. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE CATHETER AND THE ANALYSIS NOTED A PINHOLE IN THE BALLOON ABOVE THE DISTAL MARKER. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS CONCLUDED THAT THE BALLOON FAILURE MAY HAVE BEEN ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. THE LEAK WAS CONFIRMED TO BE LOCATED ABOVE THE DISTAL MARKER ALONG A BALLOON FOLD/CREASE. THERE WAS ALSO A SLIGHT RIDGE OBSERVED IN THE DISTAL MARKER. IN THIS CASE, THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, WHICH MAY INDICATE THAT THE RUPTURE WAS NOT PRESENT PRIOR TO THE PROCEDURE. HOWEVER, IT IS POSSIBLE THAT THE BALLOON AND MARKER WERE DAMAGED/PINCHED DURING MANUFACTURING SUCH THAT UPON THE INFLATION ATTEMPT, THE BALLOON RUPTURED AS A RESULT OF THE DAMAGE, THOUGH THIS CANNOT BE CONFIRMED. BALLOON MATERIAL RUPTURE/LEAK RESULTING IN AN INFLATION ISSUE CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING PROCESSING OF THE BALLOON MATERIAL, MATERIALS, INFLATION TECHNIQUE, INTERACTIONS WITH OTHER DEVICES, A PREVIOUSLY IMPLANTED STENT, LESION CALCIFICATION AND TORTUOSITY OR INSUFFICIENT PREPARATION PRIOR TO USE. REPORTEDLY, THERE WAS NO CALCIFICATION OR TORTUOSITY IN THE VESSEL/LESION, WHICH MAY SUGGEST THAT THE PATIENT ANATOMY DID NOT CONTRIBUTE TO THE EXPERIENCED RUPTURE. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL ON-LINE INSPECTIONS AND TESTING MET MANUFACTURING CRITERIA. A QUERY OF THE COMPLAINT-HANDLING DATABASE ALSO DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FROM THIS LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MID LEFT ANTERIOR DESCENDING ARTERY, AFTER DEPLOYMENT OF THE NON-ABBOTT STENT, THE NC TREK WAS ADVANCED AND POSITIONED JUST WITHIN THE STENT WHEN FLUOROSCOPY WAS INJECTED TO CONFIRM PLACEMENT. IT WAS NOTED PRIOR TO ANY INFLATION ATTEMPT THAT CONTRAST MEDIA WAS LEAKING DOWN THE VESSEL AND THE NC TREK BALLOON WAS RUPTURED/LEAKED. THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT INCIDENT AND A 3.0 X 15 MM NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. 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 1011261

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR