BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1972064 · Received January 27, 2011

    Report

    Report Number
    2024168-2011-00495
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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. DIL CATH: DURASTAR 2.5 X 15MM, MINI TREK 2.0X20 (PART 1012270-20, LOT# 0073161). GUIDE WIRE: BALANCE MIDDLEWEIGHT UNIVERSAL II. STENT: XIENCE PRIME 2.5 X 38MM. THE MINI TREK 2.0X20 (PART 1012270-20, LOT# 0073161) IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED CATHETER NOTED BLOOD AND CONTRAST VISIBLE IN THE INFLATION LUMEN, AND THE BALLOON WAS LOOSELY-FOLDED, WHICH IS CONSISTENT WITH THE REPORTED USE OF THE DEVICE LEAK OR BALLOON RUPTURE. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE CATHETER TO RATED BURST PRESSURE (RBP), BUT THE BALLOON WOULD NOT INFLATE DUE TO THE DRIED BLOOD AND CONTRAST NOTED. THEREFORE, THE DEVICE WAS LEFT IN A WATER BATH OVERNIGHT TO DISSOLVE THE BLOOD AND CONTRAST AND THE ANALYSIS CONFIRMED THAT THERE WAS A 2.5 MM RADIAL RUPTURE IN THE BALLOON, 5 MM DISTAL TO THE DISTAL MARKER BAND. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT IS NOT LIMITED TO, BALLOON DAMAGE DURING PROCESSING OF THE BALLOON MATERIAL, MATERIALS, INFLATION TECHNIQUE, INTERACTIONS WITH OTHER DEVICES, A PREVIOUSLY IMPLANTED STENT, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. BASED ON THE INFORMATION PROVIDED, THE LESION WAS MODERATELY CALCIFIED AND MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS DETERMINED THAT THE BALLOON FAILURE MAY HAVE BEEN ATTRIBUTED TO MECHANICAL DAMAGE ON THE OUTER SURFACE OF THE BALLOON. IN THIS CASE, SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS SUGGESTS THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. ADDITIONALLY, THE BALLOON WAS INITIALLY PRESSURIZED MULTIPLE TIMES WITHOUT INCIDENT, WHICH MAY HAVE CONTRIBUTED TO THE EXPERIENCED RUPTURED. THE BALLOON MATERIAL LIKELY BECAME DAMAGED (SCRATCHED) FROM INTERACTIONS WITH OTHER DEVICES AND/OR THE CALCIFIED LESION SUCH THAT AFTER MULTIPLE INFLATION ATTEMPTS, THE BALLOON RUPTURED. IT WAS ALSO REPORTED THAT THE BALLOON WAS NOT SOAKED IN SALINE PRIOR TO USING THE DEVICE, WHICH MAY HAVE ALSO CONTRIBUTED TO THE REPORTED COMPLAINT. IT SHOULD BE NOTED THAT THE VOYAGER NC INSTRUCTIONS FOR USE STATES: SUBMERGE THE BALLOON IN STERILE HEPARINIZED NORMAL SALINE DURING BALLOON PREPARATION TO ACTIVATE THE COATING. ALSO NOTED DURING THE ANALYSIS WAS A KINK IN THE SHAFT 1.5 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. HOWEVER, THIS DAMAGE WAS NOT ORIGINALLY REPORTED AND LIKELY OCCURRED FROM FURTHER HANDLING AS THE DEVICE WAS PACKAGED FOR SHIPMENT BACK TO ABBOTT VASCULAR. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO OR HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION RECEIVED AND THE ANALYSIS OF THE DEVICE, THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE DEVICE AND IS NOT A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RBP AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL REPORTED INFORMATION INDICATES THAT THE BALLOON WAS NOT SUBMERGED IN SALINE DURING BALLOON PREPARATION. ADDITIONALLY, THE BALLOON RUPTURE OCCURRED AFTER THE THIRD INFLATION DURING DILATATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PRE-DILATATION IN THE MODERATELY CALCIFIED MID CIRCUMFLEX ARTERY, THE 2.0X20 MINI TREK BALLOON WAS INFLATED TO 12 ATMOSPHERES AND RUPTURED. THE DEVICE WAS EASILY REMOVED FROM THE ANATOMY. A 2.5X12 VOYAGER NC BALLOON WAS ADVANCED AND INFLATED TO 16 ATMOSPHERES AND A RUPTURE OCCURRED. THE DEVICE WAS EASILY REMOVED FROM THE ANATOMY. DILATATION WAS SUCCESSFULLY PERFORMED USING A NON-ABBOTT DEVICE. THERE WAS NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 9030961

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR