BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 2171643 · Received July 21, 2011

    Report

    Report Number
    2024168-2011-05069
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. GUIDE WIRE: BALANCE MIDDLEWEIGHT. GUIDE CATH: 6 F JL3.5. SHEATH: 6 F. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED THE BALLOON CATHETER WAS RETURNED WITH THICK CONTRAST VISIBLE IN THE INFLATION LUMEN AND IN THE LOOSELY-FOLDED BALLOON, WHICH IS CONSISTENT WITH AN ATTEMPT TO INITIALLY PRESSURIZE THE BALLOON. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE CATHETER, BUT THE BALLOON WOULD NOT INFLATE DUE TO THE THICK CONTRAST NOTED. THEREFORE, THE DEVICE WAS LEFT PRESSURIZED OVERNIGHT TO DISSOLVE CONTRAST AND THE ANALYSIS CONFIRMED THAT THERE WAS A PINHOLE IN THE BALLOON APPROXIMATELY 3 MM PROXIMAL TO THE DISTAL BALLOON SHOULDER. SCANNING ELECTRON MICROSCOPY (SEM) LAB ANALYSIS DETERMINED THAT BALLOON FAILURE MAY HAVE BEEN ATTRIBUTED TO MECHANICAL DAMAGE ON THE OUTER SURFACE OF THE BALLOON. AS THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS MAY INDICATE THE BALLOON WAS NOT DAMAGED PRIOR TO USE. IN THIS CASE, THE BALLOON MATERIAL LIKELY BECAME DAMAGED (SCRATCHED) AND WEAKENED FROM AN INTERACTION WITH OTHER DEVICES AND/OR THE CALCIFIED LESION, SUCH THAT IT RUPTURED UPON INFLATION ATTEMPT. BALLOON MATERIAL RUPTURES RESULTING IN AN INFLATION ISSUE (FAILURE TO INFLATE) CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT 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. ALTHOUGH THERE WERE NO LEAKS NOTED DURING DEVICE PREPARATION, ADDITIONAL INFORMATION RECEIVED FROM THE ACCOUNT STATED THAT THE DEVICE WAS PREPARED INSIDE THE BODY. IT WAS ALSO NOTED THAT THE BALLOON WAS NOT SOAKED PRIOR TO USE, WHICH CAN CONTRIBUTE TO A BALLOON RUPTURE. IT SHOULD BE NOTED THE VOYAGER INSTRUCTIONS FOR USE (IFU) STATES: SUBMERGE THE BALLOON IN STERILE HEPARINIZED NORMAL SALINE DURING BALLOON PREPARATION TO ACTIVATE THE COATING. THE IFU FURTHER CAUTIONS: ALL AIR MUST BE REMOVED FROM THE BALLOON AND DISPLACED WITH CONTRAST PRIOR TO INSERTING INTO THE BODY; OTHERWISE, COMPLICATIONS MAY OCCUR. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE (RBP) AND BALLOON INTEGRITY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. FURTHERMORE, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FROM THIS LOT. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND NOT A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    SUBSEQUENT TO FILING THE INITIAL MEDWATCH, ADDITIONAL INFORMATION WAS RECEIVED. THE VOYAGER CATHETER WAS NOT PREPPED UNTIL IT WAS INSIDE THE PATIENT. ADDITIONALLY, THE BALLOON WAS NOT SUBMERGED IN SALINE PRIOR TO USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE HEAVILY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD), THE 2.0 X 12 MM VOYAGER WAS ADVANCED TO THE LESION. IT WAS ATTEMPTED TO BE PRESSURIZED, BUT THE BALLOON WOULD NOT INFLATE. A BALLOON RUPTURE WAS SUSPECTED. ANOTHER VOYAGER OF THE SAME SIZE WAS ADVANCED AND SUCCESSFULLY TREATED THE TARGET LESION. THERE WAS NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1012162

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR