BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 18432202 · Received January 2, 2024

    Report

    Report Number
    2124215-2023-74191
    Event Type
    Injury
    Date Received
    January 2, 2024
    Date of Event
    January 6, 2019
    Report Date
    February 21, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    PMA / PMN Number
    K951034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: KARPPINEN, T., KANTOLA, E., KARPPINEN, A., RANTAMKI, A., KAUTIAINEN, H., MORDON, S., & GUINA, M. (2019). TREATMENT OF TELANGIECTASIA ON THE CHEEKS WITH A COMPACT YELLOW (585NM) SEMICONDUCTOR LASER AND A GREEN (532NM) KTP LASER: A RANDOMIZED DOUBLEBLINDED SPLITFACE TRIAL. LASERS IN SURGERY AND MEDICINE, 51(3), 223229. HTTPS://DOI.ORG/10.1002/LSM.23051.

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: KARPPINEN, T., KANTOLA, E., KARPPINEN, A., RANTAMKI, A., KAUTIAINEN, H., MORDON, S., & GUINA, M. (2019). TREATMENT OF TELANGIECTASIA ON THE CHEEKS WITH A COMPACT YELLOW (585NM) SEMICONDUCTOR LASER AND A GREEN (532NM) KTP LASER: A RANDOMIZED DOUBLEBLINDED SPLITFACE TRIAL. LASERS IN SURGERY AND MEDICINE, 51(3), 223229. HTTPS://DOI.ORG/10.1002/LSM.23051 THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED PATIENT SYMPTOMS ARE A KNOWN RISK ASSOCIATED WITH IMPLANT OF THESE DEVICES AS INDICATED IN THE INSTRUCTIONS FOR USE. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN LASERS IN SURGERY AND MEDICINE THAT A STUDY WAS CONDUCTED TO COMPARE A TRADITIONAL GREEN KTP LASER (AURA XP) TO A NEW INVESTIGATIONAL YELLOW LASER (PHOTOLASE) IN THE TREATMENT OF FACIAL TELANGIECTASIA IN TERMS OF THE TREATMENT OUTCOMES. A TOTAL OF 18 SUBJECTS WERE RANDOMIZED TO RECEIVE KTP TREATMENT ON ONE SIDE OF THE FACE AND PHOTOLASE ON THE CONTRALATERAL SIDE. ONE OR TWO TREATMENTS WERE GIVEN BASED ON THE RESPONSE OF THE FIRST TREATMENT. IN THE ASSESSMENT, IT WAS OBSERVED THAT THE AMOUNT OF PAIN WAS HIGHER WITH PHOTOLASE COMPARED TO AURA XP. THERE WAS NO DIFFERENCE IN THE FREQUENCY OF ERYTHEMA, CRUSTING OR PURPURA BETWEEN THE DEVICES, BUT MORE BLISTERING AND LESS EDEMA WERE SEEN AFTER PHOTOLASE TREATMENT. THE ADVERSE REACTIONS AT THE AURA SIDE WERE THE FOLLOWING: 17 PATIENTS HAD ERYTHEMA, 7 HAD CRUSTING, 16 HAD EDEMA, 5 HAD PURPURA AND 3 MILD BLISTERS. THE STUDY CONCLUDED THAT THE INVESTIGATIONAL PHOTOLASE LASER ENABLES SIGNIFICANTLY FASTER TREATMENTS, BUT THE PROCESS IS SOMEWHAT MORE PAINFUL THAN WITH KTP, OTHERWISE PROVIDING A SIMILAR CLINICAL OUTCOME IN THE TREATMENT OF FACIAL TELANGIECTASIA.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN LASERS IN SURGERY AND MEDICINE THAT A STUDY WAS CONDUCTED TO COMPARE TREATMENT OUTCOMES OF USING A TRADITIONAL GREEN KTP LASER (AURA XP) TO THOSE USING A NEW INVESTIGATIONAL YELLOW LASER (PHOTOLASE) IN THE TREATMENT OF FACIAL TELANGIECTASIA. A TOTAL OF 18 SUBJECTS WERE RANDOMIZED TO RECEIVE KTP TREATMENT ON ONE SIDE OF THE FACE AND PHOTOLASE ON THE CONTRALATERAL SIDE. ONE OR TWO TREATMENTS WERE GIVEN BASED ON THE RESPONSE OF THE FIRST TREATMENT. IN THE ASSESSMENT, IT WAS OBSERVED THAT THE LEVEL OF PAIN REPORTED WAS HIGHER WITH PHOTOLASE COMPARED TO AURA XP. THERE WAS NO DIFFERENCE IN THE FREQUENCY OF ERYTHEMA, CRUSTING, OR PURPURA BETWEEN THE DEVICES. MORE BLISTERING AND LESS EDEMA WERE SEEN AFTER PHOTOLASE TREATMENT. THE ADVERSE REACTIONS AT THE AURA SIDE WERE THE FOLLOWING: 17 PATIENTS HAD ERYTHEMA, 7 HAD CRUSTING, 16 HAD EDEMA, 5 HAD PURPURA AND 3 HAD MILD BLISTERS. THE STUDY CONCLUDED THAT THE INVESTIGATIONAL PHOTOLASE LASER ENABLES SIGNIFICANTLY FASTER TREATMENTS, BUT THE PROCESS IS SOMEWHAT MORE PAINFUL THAN WITH KTP, OTHERWISE PROVIDING A SIMILAR CLINICAL OUTCOME IN THE TREATMENT OF FACIAL TELANGIECTASIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614902 UNKNOWN POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION UNK-P-AURA CONSOLE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R