BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2729886 · Received September 6, 2012

    Report

    Report Number
    2024168-2012-05605
    Event Type
    Malfunction
    Date Received
    September 6, 2012
    Date of Event
    August 9, 2012
    Report Date
    August 13, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. ADD'L DEVICES: GUIDE WIRE: RUNTHROUGH(2); INFLATION: DORPHINE; GUIDE CATH: 6F, TERUMO IL 4; SHEATH: 6F. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS AND CONFIRMED THE REPORTED DIFFICULTY IN DEFLATION. AS PART OF THE INVESTIGATION, A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT WAS PERFORMED AND REVEALED NO NONCONFORMING MATERIAL RECORDS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND REVEALED NO OTHER INCIDENTS REPORTED FROM THIS LOT. THE ANALYSIS OF THE DEVICE USING MAGNIFICATION CONFIRMED THAT THE INNER MEMBER (IM) WAS COMPLETELY COLLAPSED THUS CONFIRMING THE REPORTED DEFLATION ISSUES. THE REDUCTION OF THE ANNULAR SPACE IN THE IM MATERIAL WOULD CAUSE SLOW DEFLATION OF THE BALLOON. HOWEVER, THE STRETCHING OF THE IM MATERIAL JUST PROXIMAL TO THE DISTAL BALLOON MARKER SUGGESTS THAT THERE MAY HAVE BEEN POTENTIAL INTERACTION OF THE IM WITH THE GUIDEWIRE USED DURING THE PROCEDURE WHICH CAUSED THE STRETCHING OF THE IM MATERIAL. THIS TYPE OF IM DAMAGE IS NOT CONSISTENT WITH A MANUFACTURING PROCESS DISCREPANCY. IT IS HIGHLY UNLIKELY THAT THE IM WAS COLLAPSED DURING THE MANUFACTURING PROCESS AS THE UNIT DID PASS THE ON LINE LEAK TESTING PROCESS WHICH INFLATES/DEFLATES THE BALLOON. ADDITIONALLY, THE UNIT DID PASS THE GUIDEWIRE MOVEMENT TEST PERFORMED DURING THE LEAK TESTING PROCESS, CONFIRMING NO PRODUCT DEFICIENCY. THIS TYPE OF REPORTED COMPLAINT WILL CONTINUE TO BE MONITORED PER LOCAL QUALITY PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTALLY OCCLUDED LESION LOCATED IN THE CIRCUMFLEX (CX) BELOW THE BIFURCATION. TWO NON-ABBOTT GUIDE WIRES WERE ADVANCED TO THE DISTAL LEFT CX (LCX), AND OBTUSE MARGINAL 2 (OM). A 2.0X20 MM MINI TREK BALLOON CATHETER WAS USED TO PREDILATE BOTH BRANCHES OF THE OM2 PRE AND OSTIAL LCX. AFTER SUCCESSFUL PREDILATATION THE DILATATION BALLOON, DEFLATION OF THE BALLOON WAS SLOW AND DIFFICULT; HOWEVER, THE BALLOON WAS FULLY DEFLATED WHEN IT WAS REMOVED FROM THE PATIENT. NO RESISTANCE WAS FELT DURING RETRACTION OF THE BALLOON CATHETER FROM THE PATIENT. A NEW 2.0X20 MM MINI TREK BALLOON WAS USED TO COMPLETE PREDILATATION AND THE BALLOON DEFLATED SMOOTHLY. THE PROCEDURE CONTINUED ON WITH THE PLACEMENT OF THREE STENTS FOR TREATMENT OF THE LESION WITHOUT FURTHER ISSUE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE 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 2040561

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR