BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2063081 · Received April 19, 2011

    Report

    Report Number
    2024168-2011-02734
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 25, 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. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE ON THE BALLOON AND CONTRAST IN THE INFLATION LUMEN AND LOOSELY FOLDED BALLOON, CONSISTENT WITH PREPARATION AND USE OF THE PRODUCT IN THE PATIENT ANATOMY. THERE WAS BALLOON PEELING IN THE DISTAL UNSEALED PORTION OF THE BALLOON AND BALLOON PEELING 1.5 CM DISTAL TO THE MARKER FOR A LENGTH OF 2 MM, WHICH CAN BE A RESULT OF AN INTERACTION WITH THE HEAVILY CALCIFIED LESION AS THE PEELING WAS NOT REPORTED WITH THE INCIDENT INFORMATION. THERE WAS A KINK IN THE INNER MEMBER 2 MM PROXIMAL TO THE MARKER. THE INNER MEMBER WAS COLLAPSED 5 MM PROXIMAL TO THE MARKER FOR A LENGTH OF 2 MM. THE INNER MEMBER WAS ALSO COLLAPSED 4.5 CM PROXIMAL TO THE PROXIMAL SEAL FOR A LENGTH OF 2 MM. THERE WAS A KINK IN THE DISTAL SHAFT 4.6 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. THERE WERE MULTIPLE BENDS IN THE HYPOTUBE DISTAL TO THE STRAIN RELIEF TUBING FOR A LENGTH OF 75 CM. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE HYPOTUBE BENDS MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO OR HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES WITH THE GUIDE WIRE. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO RETRACT THE CATHETER OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT NOT LIMITED TO, DEVICE PLACEMENT TECHNIQUE, GUIDING CATHETER SUPPORT, INNER DIAMETER OF GUIDE WIRE LUMEN, OUTER DIAMETER OF THE GUIDE WIRE, CONDITION OF THE GUIDE WIRE, BUILD UP OF BLOOD OR CONTRAST, OR DAMAGE TO THE CATHETER. AN ATTEMPT WAS MADE TO MEASURE THE INNER DIAMETER OF THE GUIDE WIRE LUMEN WITH A FULL LENGTH MANDREL; HOWEVER THERE WAS STRONG RESISTANCE AT THE COLLAPSED INNER MEMBER PROXIMAL TO THE MARKER AND AT THE COLLAPSED INNER MEMBER 4.5 CM PROXIMAL TO THE PROXIMAL SEAL. THE GUIDE WIRE USED IN THE PROCEDURE WAS NOT RETURNED FOR ANALYSIS THEREFORE IT IS UNKNOWN HOW IT MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. A NEW GUIDE WIRE WAS BACK LOADED THROUGH THE BALLOON CATHETER WITH NO RESISTANCE NOTED. AFTER THE NEW GUIDE WIRE WAS BACK LOADED THROUGH THE BALLOON CATHETER, A NEW INDEFLATOR, FILLED WITH GASTROGRAFIN, DILUTED 1:1 WITH WATER, WAS USED TO INFLATE THE BALLOON TO THE RATED BURST PRESSURE (RBP) OF 14ATM AND AN ATTEMPT WAS MADE TO MOVE THE GUIDE WIRE WHILE THE BALLOON WAS INFLATED BUT THE GUIDE WIRE WOULD NOT MOVE. THE INNER MEMBER WAS COLLAPSED AROUND THE GUIDE WIRE PROXIMAL TO THE MARKER. AFTER THE BALLOON WAS DEFLATED, THE GUIDE WIRE WAS REMOVED FROM THE BALLOON CATHETER WITH NO RESISTANCE NOTED. INNER MEMBER COLLAPSE CAN BE A RESULT OF A MATERIAL DISCREPANCY, INCORRECT PREPARATION FOR USE, GUIDE WIRE SIZE SELECTION, OR HIGH PRESSURE/MULTIPLE INFLATIONS, AND AS THE GUIDE WIRE LUMEN WAS NOTED TO BE NOT COLLAPSED AFTER PRESSURIZATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AS THIS IS ACCEPTABLE PER THE PRODUCT SPECIFICATION. AS THE NOTED KINKS IN THE DISTAL SHAFT AND INNER MEMBER DID NOT CONTRIBUTE TO THE REPORTED RESISTANCE WITH THE GUIDE WIRE, THE KINKS LIKELY OCCURRED DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. ADDITIONALLY, IT WAS REPORTED THE MINI TREK WAS INFLATED TO 16 ATM, WHICH IS ABOVE THE RATED BURST PRESSURE (RBP). IT SHOULD BE NOTED THE INSTRUCTIONS FOR USE (IFU) STATES: BALLOON PRESSURE SHOULD NOT EXCEED THE RATED BURST PRESSURE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO SIMILAR INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND CHECKED FOR PROPER GUIDE WIRE MOVEMENT ON THE MANUFACTURING LINE. ADDITIONALLY, DURING LOT RELEASE TESTING, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO ENSURE PROPER GUIDE WIRE REVERSIBILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING WHICH WAS MODERATELY TORTUOUS, HEAVY CALCIFIED AND 99% STENOSED. THE TREK BALLOON CATHETER WAS ADVANCED OVER A NON-ABBOTT GUIDE WIRE. THERE WAS NO RESISTANCE NOTED WHILE ADVANCING THE TREK BALLOON CATHETER OVER THE GUIDE WIRE. THE BALLOON WAS THEN INFLATED UP TO 16 ATMOSPHERES AND DEFLATED WITHOUT ANY PROBLEMS. WHEN AN ATTEMPT WAS MADE TO REMOVE THE TREK, THE GUIDE WIRE WAS ALSO REMOVED UNINTENTIONALLY, AS THE TREK AND THE GUIDE WIRE HAD BECOME STUCK TOGETHER. THE DEVICES WERE REMOVED FROM THE VESSEL AS A SINGLE UNIT. OUTSIDE THE ANATOMY, THE DEVICES WERE SEPARATED AND TESTED OUTSIDE THE PATIENTS BODY. AN ATTEMPT WAS MADE TO ADVANCE THE TREK BALLOON CATHETER OVER THE GUIDE WIRE OUTSIDE THE BODY, BUT RESISTANCE WAS MET. 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 0081961

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: RINATO, SION BLUE