BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2233176 · Received September 2, 2011

    Report

    Report Number
    2024168-2011-06126
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    June 29, 2011
    Report Date
    August 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED RX MINI TREK DILATATION CATHETER NOTED THICK BLOOD AND CONTRAST VISIBLE IN THE INFLATION LUMEN CONSISTENT WITH PREPARATION AND A RUPTURE DURING USE IN THE PATIENT ANATOMY. THE BALLOON HAD LOOSE FOLDS. THERE WERE TWO BENDS IN THE HYPOTUBE 12 CM AND 66 CM DISTAL TO THE STRAIN RELIEF TUBING. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE 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 BALLOON RUPTURE. USING A NEW INDEFLATOR FILLED WITH WATER, AN ATTEMPT WAS MADE TO PRESSURIZE THE BALLOON; HOWEVER, THE FLUID DID NOT ADVANCE BECAUSE OF THE THICK BLOOD AND CONTRAST. THE BALLOON CATHETER WAS LEFT PRESSURIZED FOR 1 DAY; AND THE BALLOON WAS STILL UNABLE TO BE PRESSURIZED. UNDER THE MICROSCOPE AT 15.8 MAGNIFICATION, A PINHOLE WAS LOCATED IN THE MIDDLE OF THE BALLOON 1.1 CM DISTAL TO THE PROXIMAL SEAL. THERE WAS A SCRATCH ON THE BALLOON. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURES INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, WEAK MATERIALS, EXCESSIVELY APPLIED PRESSURE, OR INTERACTIONS WITH ACCESSORY DEVICES, PATIENT ANATOMY, AND/OR LESION CALCIFICATION OR TORTUOSITY. THERE WAS NO REPORT OF ANY LEAK IN THE CATHETER NOTED DURING PREPARATION FOR USE, WHICH WOULD SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE. THE PATIENT ANATOMICAL CONDITIONS WERE NOT REPORTED WITH THE CASE INFORMATION; HOWEVER, IT WAS REPORTED THE BALLOON WAS INFLATED TO 17 ATMOSPHERES, WHICH IS ABOVE THE RATED BURST PRESSURE, WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT SHOULD BE NOTED THE MINI TREK RX CORONARY DILATATION CATHETER INSTRUCTIONS FOR USE (IFU) STATES: BALLOON PRESSURE SHOULD NOT EXCEED THE RATED BURST PRESSURE (RBP). THE ANALYSIS OF THE RETURNED DEVICE DID NOT INDICATE ANY EVIDENCE OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT REVEALED NO ASSOCIATED NONCONFORMING MATERIAL RECORDS, INDICATING ALL LOT RELEASE TESTING MET SPECIFICATION. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED NO SIMILAR INCIDENTS REPORTED FOR BALLOON RUPTURES. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RBP.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MINI TREK, THAT WAS PREPPED PROPERLY, RUPTURED DURING TREATMENT OF A LESION IN THE RIGHT CORONARY ARTERY AT 17 ATMOSPHERES (ABOVE THE RATED BURST PRESSURE) FOR 30 SECONDS. A NON-ABBOTT BALLOON CATHETER WAS USED INSTEAD. NO ADVERSE PATIENT SEQUELA WAS REPORTED. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS 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 0072461

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR