BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIGUIDE FIBER OPTIC DIFFUSER

    MDR report key: 20585030 · Received November 1, 2024

    Report

    Report Number
    3010119152-2024-00010
    Event Type
    Injury
    Date Received
    November 1, 2024
    Report Date
    November 1, 2024
    Manufacturer
    PINNACLE BIOLOGICS INC
    Product Code
    MVG
    PMA / PMN Number
    PMA P940010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    N/A NO MALFUNCTION/PQC REPORTED WITH DEVICE. 0 H3 OTHER TEXT : NO MALFUNCTION/PQC REPORTED WITH DEVICE.

    Description of Event or Problem · 0

    TRACHEAL STRICTURE [TRACHEAL STENOSIS] . DIFFICULTY IN BREATHING [DYSPNOEA] . PHOTOFRIN FOR TUMOR IN THE TRACHEA [PRODUCT USE IN UNAPPROVED INDICATION] . CASE NARRATIVE: CASE NUMBER (B)(4) IS A SPONTANEOUS REPORT RECEIVED FROM A PHYSICIAN VIA MEDICAL INFORMATION DEPARTMENT ((B)(6)) (REFERENCE ID: (B)(4)) ON 07-OCT-2024. THIS REPORT REFERS TO A FEMALE PATIENT OF UNKNOWN AGE WHO HAD DYSPNOEA (DIFFICULTY BREATHING) AND TRACHEAL STENOSIS (TRACHEAL STRICTURE) WHILE ON TREATMENT WITH PHOTODYNAMIC THERAPY (PDT) (PHOTOFRIN, OPTIGUIDE FIBER OPTIC DIFFUSER, 630 PDT LASER) FOR TUMOR IN THE TRACHEA (PRODUCT USE IN UNAPPROVED INDICATION). THE PATIENT'S MEDICAL HISTORY, HISTORICAL MEDICATION, CURRENT CONDITION AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. ON (B)(6) 2024, THE PATIENT STARTED ON PHOTOFRIN 2 MG/KG WHICH WAS INJECTED OVER 3-5 MIN (SINGLE DOSE) FOR THE TUMOR IN THE TRACHEA. ON 03-JUL-2024, THE PATIENT WAS TREATED WITH PDT TO THE TUMOR IN THE TRACHEA. ON (B)(6) 2024THE PATIENT HAD A BRONCHOSCOPY DONE BUT NO FURTHER PDT WAS NEEDED. THE PATIENT HAD TO BE HOSPITALIZED THE WEEK OF SEPTEMBER 24TH FOR DIFFICULTY BREATHING. SHE HAD A TRACHEAL STRICTURE AND ON (B)(6) 2024, THE PATIENT HAD TRACHEA DILATION WHICH WAS DONE BY PHYSICIAN. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE EVENTS DYSPNOEA, TRACHEAL STENOSIS AND PRODUCT USE IN UNAPPROVED INDICATION WAS UNKNOWN. THE ACTION TAKEN WITH PHOTOFRIN WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE RESULT WERE NOT APPLICABLE WITH RESPECT TO PHOTOFRIN. THIS CASE IS CONSIDERED SERIOUS DUE TO SERIOUSNESS CRITERIA HOSPITALIZATION FOR THE EVENT DYSPNOEA, AND DUE TO SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT FOR THE EVENT TRACHEAL STENOSIS (INTERVENTION REQUIRED) AND EVENT PRODUCT USE IN UNAPPROVED INDICATION IS CONSIDERED TO BE NON-SERIOUS. THE REPORTER CONSIDERED THE EVENTS DYSPNOEA, TRACHEAL STENOSIS AND PRODUCT USE IN UNAPPROVED INDICATION AS POSSIBLY RELATED TO PHOTODYNAMIC THERAPY. CONSENT TO FOLLOW UP WITH THE REPORTER WAS GRANTED HOWEVER CONSENT WITH PATIENT WAS DENIED. ON 17-OCT-2024, FOLLOW-UP INFORMATION RECEIVED. IT WAS REPORTED THAT THE REPORTER WAS CONTACTED FOR A FOLLOW-UP; HOWEVER, A RESPONSE WAS NEVER RECEIVED UNFORTUNATELY. AS ALL FOLLOW-UP HAS BEEN COMPLETED, THE CASE HAS BEEN CONSIDERED AS CLOSED. CASE COMMENTS: THE CASE IS ASSESSED AS SERIOUS AND UNLISTED AS PER THE COMPANY RSI. THE COMPANY CONSIDERED THE EVENTS OF DYSPNOEA AND TRACHEAL STENOSIS TO BE POSSIBLY RELATED TO PORFIMER SODIUM (PHOTOFRIN), OPTIGUIDE FIBER OPTIC DIFFUSER AND 630 PDT LASER, AS PER THE WHO CAUSALITY CLASSIFICATION SYSTEM AS THE CONTRIBUTORY ROLE OF THE DRUG CANNOT BE EXCLUDED IN VIEW OF THE PLAUSIBLE TEMPORAL ASSOCIATION. ADDITIONALLY, LIMITED DETAILS REGARDING OUTCOME OF THE EVENTS PRECLUDES COMPREHENSIVE ASSESSMENT OF THE CASE. THE COMPANY CONSIDERED THE EVENT OF PRODUCT USE IN UNAPPROVED INDICATION TO BE POSSIBLY RELATED TO PORFIMER SODIUM (PHOTOFRIN), OPTIGUIDE FIBER OPTIC DIFFUSER AND 630 PDT LASER, AS PER CONVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963022 OPTIGUIDE FIBER OPTIC DIFFUSER FIBER MVG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R| O