BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2180151 · Received July 27, 2011

    Report

    Report Number
    2024168-2011-05276
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: FIELDER FC. GUIDE CATH: RADIGUIDE 6F JR3.5. 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. 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 RATED BURST PRESSURE (RBP). RETURN OF THE VOYAGER NC CATHETER USED IN THE PROCEDURE MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. 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 ACCESSORY DEVICES, OR THE HEAVILY CALCIFIED LESION AND IMPLANTED STENT SUCH THAT THE BALLOON RUPTURED UPON THE SECOND INFLATION AT 16 ATMOSPHERES WHICH IS BELOW THE RBP. 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 HAS BEEN NO OTHER INCIDENTS REPORTED FOR BALLOON RUPTURE FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS INSTANCE, ALTHOUGH THE DEVICE WAS NOT RETURNED FOR ANALYSIS, BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT, THE REPORTED BALLOON RUPTURES APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND NOT A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS THE RIGHT CORONARY ARTERY, VESSEL DIAMETER 4.0 MM, LESION LENGTH 13 MM, WITH MILD TORTUOSITY, HEAVY CALCIFICATION, CONCENTRIC, 85% STENOSIS AND DE NOVO. AFTER PREDILATATION WITH A TREK 2.5X15, A NON-ABBOTT STENT WAS DEPLOYED; HOWEVER, INTRAVASCULAR ULTRASOUND (IVUS) CONFIRMED THAT THE STENT WAS NOT WELL EXPANDED. SO, A VOYAGER NC 4.0X18 WAS USED FOR POST-DILATATION, BUT IT RUPTURED ON THE SECOND INFLATION AT 16 ATMOSPHERES, FOR 10-15 SECONDS. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT BALLOON. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS 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 0102261

    Patients

    Seq Age Sex Outcome Treatment
    1