BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2193266 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05554
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. DIFFICULTY TO DEFLATE THE BALLOON CAN BE AFFECTED BY, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, INFLATION TECHNIQUE WHEN USING THE PRODUCT AND ACCESSORY DEVICE SUPPORT, UNEVENLY TRIMMED HYPO-TUBE JACKET MATERIAL IN THE INFLATION PORT (HUB) CAUSING A VALVE WHEN INFLATED OR DEFLATED AND BLOCKING THE FLOW OF CONTRAST IN OR OUT OF THE BALLOON, AND/OR CONTAMINATION IN THE INFLATION LUMEN AND INNER DIAMETER OF THE SHAFT. TO HELP ENSURE THAT THE REPORTED DIFFICULTIES ARE NOT DUE TO MANUFACTURING, 100% OF THE PRODUCTS ARE LEAK TESTED AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY BALLOON DEFLATION TIMES. ADDITIONAL TREATMENT WAS USED IN THE ATTEMPTS TO DEFLATE THE BALLOON; HOWEVER THE BALLOON WAS REMOVED PARTIALLY INFLATED. IT WAS REPORTED THE RX TREK WAS NOT SOAKED PRIOR TO USE. IT SHOULD BE NOTED THE TREK INSTRUCTIONS FOR USE (IFU) STATES TO SUBMERGE THE BALLOON IN STERILE HEPARINIZED NORMAL SALINE DURING BALLOON PREPARATION TO ACTIVATE THE COATING. IT DOES NOT APPEAR THAT THE FAILURE TO SOAK THE BALLOON PRIOR TO USE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTIES DEFLATING THE BALLOON. 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. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, WITHOUT THE PRODUCT TO EXAMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 85% STENOSED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY WITH MODERATE TORTUOSITY AND MODERATE CALCIFICATION. THE 2.5 X 15 TREK BALLOON WAS ADVANCED FOR PRE-DILATATION. THE BALLOON WAS INFLATED TO 6 ATMOSPHERES (ATM) FOR8 SECONDS (SEC), 6 ATM FOR 8 SEC, 8 ATM FOR 10 SEC, AND 6 ATM FOR 12 SEC. THE TREK BALLOON WAS THEN ATTEMPTED TO BE DEFLATED; HOWEVER, THE BALLOON WOULD NOT COMPLETELY DEFLATE. AN INDEFLATOR AND A SYRINGE WERE USED TO DEFLATE THE TREK, BUT THIS WAS UNSUCCESSFUL. THE TREK WAS REMOVED PARTIALLY DEFLATED FROM THE ANATOMY, AND A VOYAGER NC BALLOON WAS USED FOR FURTHER DILATATION. THERE WERE NO ADVERSE PATIENT EFFECTS. IT WAS FURTHER NOTED THAT THE TREK BALLOON WAS NOT SUBMERGED IN SALINE DURING PREPARATION. 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 0102661

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention GUIDE WIRE: FIELDERGUIDE CATH: AR 2 6FR