BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIGUIDE FIBER OPTIC DIFFUSER

    MDR report key: 23277372 · Received October 15, 2025

    Report

    Report Number
    3010119152-2025-00014
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 13, 2025
    Manufacturer
    PINNACLE BIOLOGICS INC
    Product Code
    MVG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

    Description of Event or Problem · 0

    FIBER WAS EXTRACTED FROM THE SCOPE THE DISTAL END OF THE FIBER WAS NOT CONNECTED [DEVICE BREAKAGE]. FIBER WAS EXTRACTED FROM THE SCOPE THE DISTAL END OF THE FIBER WAS NOT CONNECTED [DEVICE FAILURE]. PHOTOFRIN USE ESOPHAGEAL [PRODUCT USE IN UNAPPROVED INDICATION]. CASE NARRATIVE: CASE NUMBER (B)(4) IS A SPONTANEOUS REPORT RECEIVED FROM OTHER HEALTH PROFESSIONAL VIA MEDICAL INFORMATION DEPARTMENT (ADVANZ PHARMA) (REFERENCE ID: AP-(B)(4)) ON (B)(6) 2025. THIS REPORT REFERS TO UNKNOWN AGE MALE PATIENT WHO HAD PRODUCT USE IN UNAPPROVED INDICATION (PHOTOFRIN USE ESOPHAGEAL), DEVICE FAILURE AND DEVICE BREAKAGE (FIBER WAS EXTRACTED FROM THE SCOPE THE DISTAL END OF THE FIBER WAS NOT CONNECTED) FOLLOWING TREATMENT WITH PHOTOFRIN (PORFIMER SODIUM). THE PATIENT'S MEDICAL HISTORY, HISTORICAL MEDICATIONS, CONCURRENT CONDITION, AND CONCOMITANT MEDICATION WERE NOT REPORTED. THE PATIENT WAS STARTED ON PHOTOFRIN AT AN UNKNOWN DOSE FOR ESOPHAGEAL DISORDER. IT WAS REPORTED THAT A 5.0 CM FLEXIBLE FIBER PLACED ADJACENTLY TO THE FIRST TREATMENT AREA. FIBER USED TO TREAT AN AREA WITH A DOSAGE OF 300 J/CM. THE AREA WAS TREATED FOR 750 SECONDS FOR A TOTAL TREATMENT OF 300 J/CM WITH LASER (SERIAL: (B)(6), UNIQUE DEVICE IDENTIFIER: (UDI) (B)(4), CALIBRATION DUE DATE (B)(6) 2025). AFTER COMPLETING TREATMENT, DISTAL TIP OF THE FIBER WAS NOTED TO BE DISCONNECTED UPON EXTRACTION AFTER FIRST TREATMENT AREA (BATCH NO: DE24021, EXPIRY DATE: 20-JUN-2029). THE END WAS REMOVED FROM THE PATIENT AND APPEARED TO BE INTACT. A SECOND FIBRE WAS USED TO TREAT THE SECOND AREA (BATCH NO: DH23049 AND EXPIRY DATE: 26-OCT-2028). PICTURE OF THE BROKEN FIBRE AND IT WAS RETAINED TO BE SENT TO THE MANUFACTURER. THE PATIENT'S TREATMENT MEDICATION AND LAB TEST WERE NOT REPORTED. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE EVENTS PRODUCT USE IN UNAPPROVED INDICATION, DEVICE FAILURE AND DEVICE BREAKAGE WERE UNKNOWN. ACTION TAKEN WITH PHOTOFRIN WAS NOT APPLICABLE. DE-CHALLENGE AND RECHALLENGE RESULTS WERE NOT APPLICABLE WITH RESPECT TO PHOTOFRIN. THIS CASE IS CONSIDERED TO BE SERIOUS DUE TO SERIOUSNESS CRITERIA OTHER MEDICALLY IMPORTANT CONDITION AND INTERVENTION REQUIRED FOR EVENTS DEVICE FAILURE AND DEVICE BREAKAGE HOWEVER THE EVENT PRODUCT USE IN UNAPPROVED INDICATION WAS NON-SERIOUS. THE REPORTER CONSIDERED THE EVENT PRODUCT USE IN UNAPPROVED INDICATION TO BE POSSIBLY RELATED TO PHOTOFRIN DRUG AND OPTIGUIDE FIBER OPTIC DIFFUSER DEVICE, HOWEVER THE EVENTS DEVICE FAILURE AND DEVICE BREAKAGE CONSIDERED TO BE UNLIKELY RELATED TO PHOTOFRIN DRUG AND POSSIBLY RELATED TO OPTIGUIDE FIBER OPTIC DIFFUSER DEVICE. THE REPORTERS DID NOT PROVIDED CONSENT TO FOLLOW UP. CASE COMMENTS: THE CASE IS ASSESSED AS SERIOUS AND LISTED AS PER THE COMPANY RSI. THE COMPANY CONSIDERED THE EVENT OF PRODUCT USE IN UNAPPROVED INDICATION TO BE POSSIBLY RELATED TO PORFIMER SODIUM, AS PER CONVENTION. EVENTS DEVICE FAILURE AND DEVICE BREAKAGE TO BE UNLIKELY RELATED TO PORFIMER SODIUM DRUG, AS PER WHO CAUSALITY CLASSIFICATION SYSTEM, AS EVENTS WERE REPORTED WITH DEVICE AND NOT DRUG. THE CASE IS ASSESSED AS SERIOUS AND LISTED AS PER THE COMPANY RSI. THE COMPANY CONSIDERED THE EVENTS OF PRODUCT USE IN UNAPPROVED INDICATION, DEVICE FAILURE AND DEVICE BREAKAGE TO BE POSSIBLY RELATED TO OPTIGUIDE FIBER OPTIC DIFFUSER, AS PER CONVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184315 OPTIGUIDE FIBER OPTIC DIFFUSER FIBER MVG DE24021

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| O