BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2090355 · Received May 16, 2011

    Report

    Report Number
    2024168-2011-03500
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 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. GUIDE WIRE: RUNTHROUGH NS. GUIDE CATH: TAIGA 6F SL4.0. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CATHETER WAS RETURNED WITH CONTRAST VISIBLE IN THE INFLATION LUMEN AND THE BALLOON WAS LOOSELY-FOLDED, SUGGESTING THAT THE DEVICE WAS PREPARED FOR USE AND IS CONSISTENT WITH AN ATTEMPTED INFLATION. THERE WAS ALSO BLOOD VISIBLE IN THE GUIDE WIRE LUMEN. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE CATHETER AND THE ANALYSIS NOTED FLUID LEAKING FROM THREE LINEAR PINHOLES IN THE BALLOON ABOVE THE DISTAL MARKER, CONFIRMING THE REPORTED COMPLAINT. THE BALLOON WAS ULTIMATELY SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS, WHICH REVEALED THAT THE PINHOLES ABOVE THE DISTAL MARKER WERE DUE TO A SMALL LONGITUDINAL LEAK/TEAR LOCATED ALONG A BALLOON FOLD/CREASE. THE SEM ANALYSIS CONCLUDED THAT THE BALLOON FAILURE MAY HAVE BEEN ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. THE DISTAL BALLOON MARKER ALSO EXHIBITED A SLIGHT RIDGE IN THE MATERIAL. 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 INFLATION ATTEMPT, THE BALLOON RUPTURED AS A RESULT OF THE DAMAGE, THOUGH THIS CANNOT BE CONFIRMED. BALLOON MATERIAL RUPTURES RESULTING IN AN INFLATION ISSUE (FAILURE TO INFLATE) 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 TORTUOSITY OR CALCIFICATION IN VESSEL/LESION, HOWEVER, THE LESION WAS 90% STENOSED AND MAY HAVE CONTRIBUTED TO THE EXPERIENCED RUPTURE. IN THIS INSTANCE, A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE ALONG THE FOLD AND DAMAGE NOTED CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE TREK BALLOON WAS PLACED AT THE LESION; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION OF 4 ATMOSPHERES. ADDITIONAL DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON AND ANOTHER TREK BALLOON. A XIENCE V STENT WAS IMPLANTED AND POST-DILATATION WAS PERFORMED WITH A VOYAGER NC TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. 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 0072261

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR