BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2180158 · Received July 27, 2011

    Report

    Report Number
    2024168-2011-05273
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    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: BALANCE MIDDLEWEIGHT; GUIDE CATH: MEDTRONIC JR4 6F, 90 CM; STENT: XIENCE V (X2). EVALUATION SUMMARY: EVALUATION OF THE RETURNED TREK DILATATION CATHETER NOTED BLOOD VISIBLE IN THE INFLATION LUMEN, ON THE SHAFT, ON THE TIGHTLY FOLDED BALLOON AND INSIDE THE HUB, CONSISTENT WITH THE CATHETER ADVANCED INSIDE THE PATIENT ANATOMY. THE BALLOON CATHETER WAS RETURNED FROZEN IN THE NON-ABBOTT GUIDING CATHETER AND ADVANCED OVER A BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE. THERE WAS 38 CM OF THE DISTAL END OF THE BALLOON CATHETER EXTENDING OUT FROM THE GUIDING CATHETER TIP. THERE WERE TWO KINKS IN THE HYPOTUBE 4.3 CM AND 5.5 CM PROXIMAL TO THE GUIDE WIRE EXIT NOTCH. THERE WAS A BEND IN THE HYPOTUBE 13 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS A BEND IN THE BMW GUIDE WIRE TIP 8 MM PROXIMAL TO THE TIPBALL. THE TIP COILS WERE PUSHED DISTAL FROM THE CENTER SOLDER FOR A LENGTH OF 4 MM. THERE WAS BLOOD ON THE GUIDE WIRE COILS. A ROTATING HEMOSTATIC VALVE (RHV) WAS RETURNED ON THE BALLOON CATHETER PROXIMAL OF THE GUIDING CATHETERS LUER. THERE WAS NO DAMAGE NOTED TO THE GUIDING CATHETER. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. ALTHOUGH THE ANATOMICAL CONDITIONS WERE NOT REPORTED, FAILURE TO ADVANCE IS NOT OFTEN ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY AND IS LIKELY RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. POSSIBLE CAUSES FOR DIFFICULTY REMOVING A DILATATION CATHETER FROM THE GUIDING CATHETER MAY INCLUDE: DAMAGE TO THE BALLOON, KINKS, BENDS, OBSTRUCTIONS IN THE GUIDING CATHETER LUMEN, DAMAGE TO THE GUIDING CATHETER OR INTRODUCER SHEATH. AFTER THE RETURNED PRODUCTS WERE DECONTAMINATED, THE BALLOON CATHETER WAS REMOVED WITH NO RESISTANCE NOTED. THE COLLAPSED 2/3 BALLOON PROFILE AND TIP LENGTH WERE MEASURED AND MET MANUFACTURING CRITERIA. THE INNER DIAMETER OF THE LUER OF THE GUIDING CATHETER WAS MEASURED WITH A 0.070 INCH PIN GAUGE AND A .068 INCH PIN GAUGE WAS USED TO MEASURE THE INNER DIAMETER OF THE TIP. THE GUIDE WIRE WAS REMOVED FROM THE BALLOON WITH NO RESISTANCE NOTED. THE OUTER DIAMETER OF THE GUIDE WIRE WAS MEASURED AND MET MANUFACTURING CRITERIA. THE TIP OF THE GUIDE WIRE WAS TUGGED ON TO VERIFY THE CORE WAS STILL INTACT. THE BALLOON CATHETER WAS ADVANCED THROUGH THE NON-ABBOTT GUIDING CATHETER AND REMOVED WITH SLIGHT RESISTANCE AT THE BEND IN THE HYPOTUBE 13 CM DISTAL TO THE STRAIN RELIEF TUBING. AN INDEFLATOR, FILLED WITH WATER, WAS USED IN AN ATTEMPT TO INFLATE THE BALLOON BUT FLUID WAS OBSERVED LEAKING FROM A TEAR IN THE DISTAL SHAFT AT THE GUIDE WIRE EXIT NOTCH. THE DISTAL SHAFT WAS TORN DISTAL TO THE GUIDE WIRE EXIT NOTCH FOR A LENGTH OF 9 MM. THE TEARING OF THE GUIDE WIRE EXIT NOTCH APPEARS TO HAVE RESULTED FROM AN INTERACTION WITH THE GUIDE WIRE. THIS TYPE OF MECHANICAL DAMAGE CAN OCCUR IF AN ATTEMPT IS MADE TO PULL THE STENT DELIVERY SYSTEM IN AN OPPOSITE DIRECTION AS THE GUIDE WIRE. IN THIS CASE, IT IS LIKELY THAT THE CATHETER MET RESISTANCE IN THE ATTEMPT TO CROSS THE LESION, RESULTING IN THE NOTED KINKS AND BEND IN THE SHAFT AS THERE WAS NO DAMAGE NOTED TO THE CATHETER DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. AS THE CATHETER WAS RETRACTED, IT LIKELY ENCOUNTERED RESISTANCE WITH THE GUIDING CATHETER AT THE KINK LOCATION IN THE SHAFT. FURTHER MANIPULATION OF THE CATHETER AND GUIDE WIRE IN THE ATTEMPTS TO REMOVE THE CATHETER LIKELY RESULTED IN THE NOTED TEAR IN THE GUIDE WIRE EXIT NOTCH. 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 HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE PROFILE DIMENSIONS ON ALL DILATATION CATHETERS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, ALL DILATATION CATHETERS ARE VISUALLY INSPECTED ONLINE FOR DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PROCEDURE WAS TO TREAT A SAPHENOUS VEIN GRAFT (SVG). USING A BALANCE MIDDLEWEIGHT GUIDE WIRE (GW), TWO XIENCE V STENTS WERE SUCCESSFULLY DEPLOYED IN THE GRAFT. THE 3.0 X 15 MM TREK BALLOON CATHETER WAS THEN ADVANCED TO DO SOME DILATATION IN ANOTHER AREA OF THE SVG, BUT IT WAS UNABLE TO CROSS. THE TREK WAS RETRACTED, BUT WAS UNABLE TO BE PULLED INTO THE NON-ABBOTT GUIDE CATHETER (GC). THE BALLOON WAS WELL OUTSIDE THE GC; IT APPEARED TO BE STUCK AROUND THE SHAFT AT THE RX NOTCH; THEREFORE, ALL DEVICES WERE REMOVED TOGETHER. THERE HAD BEEN NO RESISTANCE NOTED WITH THE GW DURING USE OF THE TREK OR DURING ADVANCEMENT OR REMOVAL OF THE TWO XIENCE V STENT DELIVERY SYSTEMS. THE PROCEDURE CONTINUED USING A NEW GC, A NEW GW AND A NON-ABBOTT BALLOON. THERE WAS NO SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECT. THE PATIENT OUTCOME WAS GOOD. 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 0111061

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR