BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2073111 · Received April 29, 2011

    Report

    Report Number
    2024168-2011-03013
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 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. DILATATION CATHETER: FORTISS II; GUIDE WIRE: RUNTHROUGH, ROUTE; STENT: PROMUS 2.5 MM, 3.5 MM. EVALUATION SUMMARY: THE INABILITY TO CROSS THE LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION, DAMAGE TO THE CATHETER, INTERACTIONS WITH OTHER DEVICES, AND ACCESSORY DEVICE SUPPORT. BASED ON THE INFORMATION PROVIDED, THE LESION WAS MILDLY TORTUOUS, MILDLY CALCIFIED AND 90% STENOSED, WHICH LIKELY CONTRIBUTED TO THE REPORTED COMPLAINT. THE BALLOON CATHETER WAS RETURNED WITH BLOOD AND CONTRAST VISIBLE IN THE INFLATION LUMEN AND ON THE BALLOON, WHICH WAS TIGHTLY-FOLDED. THIS IS CONSISTENT WITH A LEAK IN THE DEVICE AND SUGGESTS THAT THE BALLOON WAS NOT ABLE TO INFLATE DURING THE PROCEDURE. THE ANALYSIS REVEALED THAT THE GUIDE WIRE EXIT NOTCH AND DISTAL SHAFT WERE TORN DISTALLY FOR A LENGTH OF 1.6 CM. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE CATHETER, BUT FLUID LEAKED FROM THE TEAR IN THE DISTAL SHAFT, CONFIRMING THE REPORTED COMPLAINT. THE ANALYSIS FURTHER NOTED THAT THE DISTAL END OF THE TIP WAS TORN. HOWEVER, SINCE THERE WAS NO REPORT OF ANY DAMAGE OBSERVED TO THE CATHETER DURING INSPECTION PRIOR TO USE, THIS SUGGESTS THAT THE DAMAGE NOTED OCCURRED AT SOME POINT DURING THE PROCEDURE. MEASUREMENTS OF THE TIP LENGTH AND THE 2/3 BALLOON PROFILE WERE ALSO TAKEN AND BOTH DIMENSIONS MET MANUFACTURING CRITERIA. IN THIS CASE, IT IS POSSIBLE THAT THE TIP OF CATHETER INTERACTED WITH THE STENT IMPLANT AND/OR THE TORTUOUS AND CALCIFIED LESION DURING ADVANCEMENT, SUCH THAT IT WAS UNABLE TO CROSS AND BECAME TORN AS A RESULT. FURTHERMORE, 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 CATHETER IN AN OPPOSITE DIRECTION AS THE GUIDE WIRE. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL ON-LINE INSPECTIONS AND TESTING MET MANUFACTURING CRITERIA. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FROM THIS LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED. BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT AND THE ANALYSIS OF THE RETURNED PRODUCT, THE REPORTED FAILURE TO ADVANCE, LEAK AND NOTED DAMAGE APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND NOT A PRODUCT QUALITY DEFICIENCY. THE PROFILE DIMENSIONS ON ALL DILATATION CATHETERS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ONLINE DURING THE MANUFACTURING PROCESS. ALL PRODUCTS ARE ALSO 100% LEAK TESTED ONLINE AND A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE AT THE BIRFUCATION OF THE LEFT ANTERIOR DESCENDING ARTERY AND THE CIRCUMFLEX ARTERY, TWO PROMUS STENTS WERE IMPLANTED. A 2.5 X 15 MM TREK DILATATION CATHETER WAS ADVANCED BUT COULD NOT CROSS THROUGH THE PROXIMAL STENT. THE PHYSICIAN ATTEMPTED TO ADVANCE A NON-ABBOTT DILATATION CATHETER WITH THE TREK; HOWEVER, THE TREK CATHETER COULD NOT CROSS THROUGH THE STENT. THE TREK BALLOON WAS INFLATED SHORT OF THE STENT. THE PHYSICIAN NOTED CONTAST LEAKING FROM THE SHAFT OF THE CATHETER. THE PROCEDURE WAS COMPLETED. 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 0090961

    Patients

    Seq Age Sex Outcome Treatment
    1