BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2183400 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05382
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED BALLOON CATHETER FOUND BLOOD VISIBLE IN THE LOOSELY FOLDED BALLOON AND INFLATION LUMEN, CONSISTENT WITH A RUPTURE WHILE IN THE PATIENT ANATOMY. THERE WERE MULTIPLE BENDS THROUGHOUT THE ENTIRE LENGTH OF THE HYPOTUBE. 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. A NEW INDEFLATOR FILLED WITH WATER WAS USED IN ATTEMPT TO INFLATE THE BALLOON TO THE RATED BURST PRESSURE (RBP), WHEN IT WAS OBSERVED THAT FLUID WAS COMING OUT FROM A PINHOLE IN THE BALLOON 1.5 MM DISTAL TO THE PROXIMAL BALLOON MARKER, CONFIRMING THE REPORTED RUPTURE. THERE WERE NO SCRATCHES FOUND. 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. THE SCANNING ELECTRON MICROSCOPY (SEM) LAB ANALYSIS NOTED THE BALLOON FAILURE MAY BE RELATED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. MECHANICAL DAMAGE WAS OBSERVED AT, AND LEADING TO THE LEAK. 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. IT IS LIKELY THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH THE HEAVILY CALCIFIED LESION, SUCH THAT THE BALLOON RUPTURED UPON THE FIRST INFLATION AT 16 ATMOSPHERES, WHICH IS BELOW THE RBP. TO ENSURE THIS IS NOT A RESULT OF MANUFACTURING, ALL BALLOON CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RBP. IT WAS REPORTED THE BALLOON WAS NOT SOAKED PRIOR TO USE. IT SHOULD BE NOTED THE NC TREK INSTRUCTIONS FOR USE STATES TO SUBMERGE THE BALLOON IN STERILE HEPARINIZED NORMAL SALINE DURING BALLOON PREPARATION TO ACTIVATE THE COATING. IT IS POSSIBLE THE FAILURE TO SOAK THE BALLOON PRIOR TO USE CONTRIBUTED TO THE REPORTED RUPTURE; HOWEVER, THIS COULD NOT BE CONFIRMED. 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 IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: PROGRESS 40. INFLATION: 20/30 PRIORITY PACK. SHEATH: 6 FR. THE SECOND 3.0 X 12 MM NC TREK AND THE 3.5 X 6 MM NC TREK ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH HEAVY CALCIFICATION. DURING THE PROCEDURE, THE FIRST NC TREK 3.0 X 12 MM BALLOON RUPTURED AT 16 ATMOSPHERES (ATM). A NEW NC TREK 3.0 X 12 MM WAS ADVANCED, BUT THIS ONE ALSO RUPTURED AT 16 ATM. THEN AN NC TREK 3.0 X 6 MM WAS ADVANCED AND ABLE TO BE USED SUCCESSFULLY. AFTER THAT AN NC TREK 3.5 X 6 MM WAS ADVANCED, BUT THIS ONE ALSO RUPTURED AT 16 ATM. THERE WAS NO RESISTANCE NOTED DURING ADVANCING OR RETRACTING THE BALLOONS. IT WAS FURTHER NOTED THAT ALTHOUGH THE CATHETERS WERE FLUSHED, THE BALLOONS WERE NOT SUBMERGED IN SALINE DURING PREPARATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1020861

    Patients

    Seq Age Sex Outcome Treatment
    1