BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2120342 · Received June 10, 2011

    Report

    Report Number
    2024168-2011-04108
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 16, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED TREK DILATATION CATHETER NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN, WHICH IS CONSISTENT WITH THE DEVICE BEING ADVANCED OVER A GUIDE WIRE. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN AND THE BALLOON WAS LOOSELY-FOLDED BALLOON, INDICATING THAT THE CATHETER WAS PREPARED FOR USE AND PRESSURIZED DURING THE PROCEDURE. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE CATHETER AND THE ANALYSIS CONFIRMED THAT THERE WAS A LONGITUDINAL RUPTURE IN THE DISTAL SHOULDER OF THE BALLOON. 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 IN THE DISTAL MARKER ALONG A BALLOON FOLD/CREASE WITH MECHANICAL DAMAGE OBSERVED AT THE LEAK EDGE. DAMAGE WAS ALSO FOUND ON THE DISTAL MARKER IN AN AREA CORRESPONDING TO THE BALLOON LEAK. ADDITIONALLY, NO EVIDENCE OF MECHANICAL DAMAGE OR OTHER ANOMALIES WERE OBSERVED ON THE INNER SURFACE OF THE BALLOON. THERE WAS NO REPORT OF ANY LEAK 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 INFLATION ATTEMPT, THE BALLOON RUPTURED AS A RESULT OF THE DAMAGE, THOUGH THIS CANNOT BE CONFIRMED. BALLOON MATERIAL RUPTURE 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. BASED ON THE INFORMATION PROVIDED, THE LESION WAS MILDLY CALCIFIED AND 75% STENOSED, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED RUPTURE. IT WAS NOTED DURING THE ANALYSIS THAT THE INNER MEMBER WAS COLLAPSED AND TWISTED PROXIMAL TO THE PROXIMAL BALLOON SEAL. HOWEVER, THIS DAMAGE WAS NOT ORIGINALLY REPORTED IN THE CASE DESCRIPTION AND MAY HAVE OCCURRED DURING OR AFTER THE PROCEDURE. INNER MEMBER COLLAPSE CAN BE A RESULT OF A MATERIAL DISCREPANCY, INCORRECT PREPARATION FOR USE, GUIDE WIRE SIZE SELECTION, OR HIGH PRESSURE/MULTIPLE INFLATIONS. IF AN ATTEMPT IS MADE TO PRESSURIZE OUTSIDE OF THE PATIENT ANATOMY WITHOUT THE SUPPORT OF THE GUIDE WIRE, THIS CAN ALSO CAUSE THE INNER MEMBER TO COLLAPSE. ADDITIONAL INFORMATION RECEIVED FROM THE ACCOUNTED STATED THAT THE DEVICE WAS NOT PRESSURIZED OUTSIDE THE ANATOMY. THERE WAS ALSO NO REPORTED RESISTANCE DURING ADVANCEMENT/RETRACTION OF THE CATHETER, INDICATING THAT THIS DAMAGE LIKELY DID NOT OCCUR DURING THE PROCEDURE. ALTHOUGH A DEFINITIVE CAUSE FOR THE INNER MEMBER COLLAPSE CANNOT BE DETERMINED, THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO THE REPORTED COMPLAINT. THERE WERE ALSO MULTIPLE BENDS FOUND IN THE ENTIRE LENGTH OF THE HYPOTUBE, WHICH LIKELY OCCURRED FROM FURTHER HANDLING AS THE DEVICE WAS PACKAGED FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR ANALYSIS. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. FURTHERMORE, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FOR BALLOON RUPTURES OR DAMAGE TO THE INNER MEMBER FROM THIS LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE ALONG THE CREASE FOLD AND NOTED DAMAGE TO THE MARKER COULD NOT BE DETERMINED. 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 THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, 75% STENOSED, CONCENTRIC, PROXIMAL LEFT ANTERIOR DESCENDING ARTERY LESION. THE 2.75 X 15 MM TREK WAS USED FOR PRE-DILATATION, BUT DURING THE FIRST INFLATION AT 6 ATMOSPHERES THE BALLOON RUPTURED. A 2.75 X 15 MM NON-ABBOTT BALLOON WAS USED IN THE PROCEDURE. A 3.0 X 18 MM AND A 3.0 X 14 MM NON-ABBOTT STENT WAS IMPLANTED IN THE LESION. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0102261

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR GUIDE WIRE: RUNTHROUGH NS