BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2002646 · Received February 28, 2011

    Report

    Report Number
    2024168-2011-01235
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE ON THE HUB, SHAFT, BALLOON, AND IN THE GUIDE WIRE LUMEN. THERE WAS CONTRAST ON THE SHAFT AND IN THE INFLATION LUMEN AND GUIDE WIRE LUMEN. THIS IS CONSISTENT WITH PREPARATION AND THE CATHETER ADVANCED OVER A GUIDE WIRE INTO THE PATIENT ANATOMY. THE BALLOON WAS FOLDED FLAT CONSISTENT WITH MULTIPLE AND HIGH PRESSURE INFLATIONS, AND WRINKLED AT THE PROXIMAL END. THE DISTAL SHAFT WAS WRINKLED PROXIMAL TO THE PROXIMAL BALLOON SEAL AT SEVERAL LOCATIONS. A NON-ABBOTT GUIDE WIRE WAS RETURNED IN THE CATHETER WITH 104.5 CM OF THE WIRE EXTENDING OUT THE TIP OF THE CATHETER. THERE WAS THICK CRYSTALLIZED CONTRAST ON THE GUIDE WIRE. THE DISTAL END OF THE TEFLON COATING WAS WRINKLED AND THE POLYMER COATING WAS WRINKLED THE ENTIRE LENGTH OF THE COATING. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO ADVANCE/RETRACT THE CATHETER OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT ARE 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. A FULL LENGTH MANDREL WAS ADVANCED THROUGH THE CATHETER MEETING MANUFACTURING CRITERIA. THE NON-ABBOTT GUIDE WIRE OUTER DIAMETER WAS MEASURED USING A LASER MICROMETER AND WAS MEASURED TO BE .0136 INCHES. AN ATTEMPT WAS MADE TO REMOVE THE GUIDE WIRE FROM THE DISTAL END OF THE CATHETER; HOWEVER THERE WAS STRONG RESISTANCE NOTED DUE TO THE THICK CONTRAST ON THE GUIDE WIRE. AFTER CLEANING THE CONTRAST OFF THE GUIDE WIRE, IT WAS REMOVED FROM THE CATHETER WITHOUT RESISTANCE. THE GUIDE WIRE WAS BACK LOADED AND FRONT LOADED THROUGH THE CATHETER WITHOUT RESISTANCE NOTED. IN THIS CASE, IT IS LIKELY THAT THE COAGULATION OF CONTRAST IN THE GUIDE WIRE LUMEN AND ON THE GUIDE WIRE CONTRIBUTED TO THE RESISTANCE WITH THE GUIDE WIRE. ADDITIONALLY, AS RESISTANCE WAS ENCOUNTERED WITH THE GUIDE WIRE, IF FORCE WAS APPLIED, IT WOULD CONTRIBUTE TO THE BALLOON AND SHAFT WRINKLING AS THERE WAS NO DAMAGE NOTED DURING THE INSPECTION PRIOR TO USE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT 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. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED DIFFICULTIES WITH THE GUIDE WIRE APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED EXPERIENCING AN S-T ELEVATED MYOCARDIAL INFARCTION (MI) AND THROMBOSIS WAS SUBSEQUENTLY IDENTIFIED. DURING THE PROCEDURE, THE BALLOON DILATATION CATHETER BECAME STUCK ON A NON-ABBOTT GUIDE WIRE REQUIRING THE DEVICES BE REMOVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH THE IMPLANTATION OF TWO XIENCE STENTS OVERLAPPING. THE PATIENT WAS FINE. NO ADDITIONAL EVENT OR PATIENT 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 0090861

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR GUIDE WIRE: CHOICE EXTRA