BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2083393 · Received May 10, 2011

    Report

    Report Number
    2024168-2011-03352
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE IN THE LOOSELY FOLDED BALLOON, CONSISTENT WITH A RUPTURE WHILE IN THE PATIENT ANATOMY. THERE WERE THREE RADIAL AND FOUR LONGITUDINAL RUPTURES IN THE PROXIMAL BALLOON TAPER AND SHOULDER. ALL OF THE RUPTURES WERE APPROXIMATELY 1 MM IN LENGTH. THERE WERE NO SCRATCHES NOTED. THERE WERE MULTIPLE KINKS IN THE FULL LENGTH OF THE DISTAL SHAFT. THE HYPOTUBE WAS KINKED 10 CM PROXIMAL TO THE GUIDE WIRE EXIT NOTCH. THERE WERE MULTIPLE BENDS IN THE FULL LENGTH OF THE HYPOTUBE. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE KINKS AND BENDS MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. ADDITIONALLY, THE LESION WAS REPORTED AS HEAVILY CALCIFIED AND MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS CONFIRMED THE MULTIPLE LEAKS IN A BALLOON. IT WAS DETERMINED THAT THE BALLOON FAILURE MAY HAVE BEEN ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. IN THIS CASE, IT IS LIKELY THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH OTHER DEVICES AND/OR THE MODERATELY CALCIFIED LESION, SUCH THAT THE BALLOON RUPTURED UPON FIRST INFLATION AT 12 ATMOSPHERES, WHICH IS BELOW THE RATED BURST PRESSURE (RBP). TO ENSURE THIS TYPE OF OCCURRENCE IS NOT A RESULT OF A POTENTIAL PRODUCT DEFICIENCY, ALL DILATATION CATHETERS ARE VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY RBP AND BALLOON INTEGRITY. BASED ON THE REPORTED INFORMATION, THE ANALYSIS OF THE RETURNED PRODUCT AND THE RESULTS OF THE SEM ANALYSIS, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. BALLOON MATERIAL RUPTURES 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. IN THIS CASE, SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS MAY INDICATE THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RBP. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT MAIN WITH MODERATE TORTUOSITY AND HEAVY CALCIFICATION. THE MINI TREK WAS ADVANCED WITH A BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL GUIDE WIRE. THE BALLOON WAS INFLATED TO 8 ATMOSPHERES FOR THE FIRST INFLATION; HOWEVER, THE BALLOON WAS NOT FULLY INFLATED. THE BALLOON PRESSURE WAS INCREASED TO 12 ATM; HOWEVER, THE BALLOON RUPTURED DUE TO SEVERE CALCIFICATION. ANOTHER MINI TREK WAS USED TO SUCCESSFULLY DILATE THE LESION. THE PATIENT WAS STABLE, AND THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1012962

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: BMW UNIVERSAL II 190CM