BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUWAVE

    MDR report key: 8428842 · Received March 18, 2019

    Report

    Report Number
    3008769756-2019-00023
    Event Type
    Injury
    Date Received
    March 18, 2019
    Date of Event
    January 1, 2017
    Report Date
    February 21, 2019
    Manufacturer
    NEUWAVE MEDICAL, INC.
    Product Code
    NEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THE LOT WAS NOT PROVIDED; THEREFORE, A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT THE NEUWAVE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: PEDIATRIC PERCUTANEOUS OSTEOID OSTEOMA ABLATION: CONE-BEAM CT WITH FLUOROSCOPIC OVERLAY VERSUS CONVENTIONAL CT GUIDANCE AUTHORS: BRANDON C. PERRY, ERIC J. MONROE, TYLER MCKAY, KALPANA M. KANAL, AND GIRIDHAR SHIVARAM. CITATION: CARDIOVASC INTERVENT RADIOL (2017) 40:1593¿1599, DOI 10.1007/S00270-017-1685-2, PUBLISHED ONLINE: 11 MAY 2017. THE AIM OF THIS SINGLE-CENTER RETROSPECTIVE STUDY IS TO COMPARE CBCT WITH FLUOROSCOPIC OVERLAY VERSUS CONVENTIONAL CT GUIDANCE FOR PERCUTANEOUS THERMAL (RFA AND MWA) ABLATION OF OSTEOID OSTEOMAS. BETWEEN JANUARY 2011 AND JULY 2016, 23 PATIENTS WITH 25 NON-SPINAL OSTEOID UNDERWENT ABLATION USING CBCT WITH FLUOROSCOPIC GUIDANCE OVERLAY. THIRTY-TWO PATIENTS WITH 35 NON-SPINAL OSTEOID OSTEOMAS UNDERWENT CONVENTIONAL CT-GUIDED OSTEOID OSTEOMA ABLATION. MEAN (RANGE): CBCT- 12.7 (3¿18), CCT- 12.9 (2¿19); GENDER: CBCT- MALE- 11 (48%), FEMALE 12 (52%) AND CCT- MALE- 20 (63%), FEMALE- 12 (37%). DURING THE PROCEDURE, CERTUS 140 MWA PROBE (NEUWAVE MEDICAL, MADISON, WI) WAS ADVANCED INTO THE DRILLED TRACT UNDER LIVE FLUOROSCOPIC GUIDANCE WITH OVERLAY ON CBCT IMAGES. ORTHOGONAL VIEWS (DOWN THE PROBE AXIS AND PERPENDICULAR TO THE PROBE) WERE USED TO GUIDE THE PROBE TO THE INTENDED DEPTH OF THE TARGET. ONCE THE PROBE REACHED THE TARGET, A FINAL CBCT CONFIRMED CORRECT POSITIONING. IF THE PROBE DID NOT REACH THE TARGET, THE TRAJECTORY WAS ALTERED USING THE MOST RECENT IMAGES AS A REFERENCE FOR FURTHER PROBE ADVANCEMENT. AFTER FINAL PROBE POSITIONING, RFA WAS PERFORMED FOR 6 MIN AFTER REACHING A TARGET TEMPERATURE OF 90 C, WHILE WITH MWA THREE TO FOUR CYCLES OF 30-S BURNS AT 30 W WERE PERFORMED. THERE WERE 2 MINOR COMPLICATIONS IN THE CBCT GROUP: TRANSIENT FOOT NUMBNESS AND THERMAL SKIN INJURY WITH SUBSEQUENT RESOLUTION. IN CONCLUSION, FLUOROSCOPIC CBCT GUIDANCE FOR PERCUTANEOUS OSTEOID OSTEOMA ABLATION YIELDS SIMILAR TECHNICAL AND CLINICAL SUCCESS, REDUCED RADIATION DOSE, AND INCREASED TOTAL ROOM UTILIZATION TIME COMPARED TO CONVENTIONAL CT GUIDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221071 UNKNOWN_NEUWAVE SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY NEUWAVE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SYSTEM - NWA1US1N