BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIGUIDE FIBER OPTIC DIFFUSER

    MDR report key: 21009806 · Received December 24, 2024

    Report

    Report Number
    3010119152-2024-00015
    Event Type
    Injury
    Date Received
    December 24, 2024
    Date of Event
    November 22, 2024
    Report Date
    June 5, 2025
    Manufacturer
    PINNACLE BIOLOGICS INC
    Product Code
    MVG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BROKEN FIBER AND PACKAGING WAS AVAILABLE TO SEND IN FOR INSPECTION. FIBER WAS SHIPPED BACK TO QUALITY DEPARTMENT ON 26-NOV-2024 FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    BROKEN FIBER AND PACKAGING WAS AVAILABLE TO SEND IN FOR INSPECTION. FIBER WAS SHIPPED BACK TO QUALITY DEPARTMENT ON (B)(6) 2024 FOR INVESTIGATION. THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

    Description of Event or Problem · 0

    THERE WAS A SMALL AREA WITHIN THE LEFT UPPER LOBE WHERE THE AIRWAY HAD BEEN CHARRED/BURNED BY THE BROKEN FIBER [AIRWAY BURNS]. THERE WAS A SMALL AREA WITHIN THE LEFT UPPER LOBE WHERE THE AIRWAY HAD BEEN CHARRED/BURNED BY THE BROKEN FIBER [DEVICE BREAKAGE]. 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 22-NOV-2024. THIS REPORT REFERS TO A 62-YEARS-OLD ADULT MALE PATIENT WHO HAD AIRWAY BURNS DUE TO DEVICE BREAKAGE (THERE WAS A SMALL AREA WITHIN THE LEFT UPPER LOBE WHERE THE AIRWAY HAD BEEN CHARRED/BURNED BY THE BROKEN FIBER) FOLLOWING TREATMENT WITH PHOTODYNAMIC THERAPY (PDT) (PHOTOFRIN, OPTIGUIDE FIBER OPTIC DIFFUSER, 630 PDT LASER). THE PATIENT'S MEDICAL HISTORY, HISTORICAL MEDICATION, CONCURRENT CONDITION, AND CONCOMITANT MEDICATION WERE NOT REPORTED. ON UNKNOWN DATE, THE PATIENT WAS STARTED ON PHOTOFRIN POWDER FOR SOLUTION FOR INJECTION AT A DOSE OF 2 MG/KG (3-5 MIN SLOW IV PUSH) VIA INTRAVENOUS ROUTE. IT WAS REPORTED THAT ON (B)(6) 2024 (APPROX. TIME WAS 12:55PM CT) DURING THE PDT PROCEDURE (1ST ILLUMINATION), 2.5 CM FLEX FIBER (LOT: DG22053, EXPIRY DATE: 25-AUG-2027) WAS VISIBLY BROKEN/FRACTURED ONCE REMOVED FROM THE PATIENT'S BODY CAVITY/LUNGS. THE ROOM NOTICED THE SMELL OF SOMETHING BURNING AND IMMEDIATELY TOOK THE FIBER OUT OF THE BODY CAVITY. THE LASER WAS SHUT OFF. UPON INSPECTION, THERE WAS A SMALL AREA WITHIN THE LEFT UPPER LOBE WHERE THE AIRWAY HAD BEEN CHARRED/BURNED BY THE BROKEN FIBER. AN AIRWAY INSPECTION OF THE BURNT LUNG TISSUE WAS DONE BY PHYSICIAN. IT WAS DECIDED TO TREAT WITH A NEW, 2.0CM FIBER IN THE SAME VICINITY FOR 180 MORE SECONDS AS IT WAS NOT ESTIMATING HOW MUCH TREATMENT WAS GIVEN IN THE AREA DUE TO THE FRACTURED FIBER. THERE WAS NO ISSUE WITH REILLUMINATION USING THE 2CM RIGID FIBER AND NO MORE DAMAGE DONE TO THE AFFECTED AREA. THE AREA OF CONCERN SEEMED CONTAINED AND THERE WAS NO SIGN OF PERFORATION AT THE SITE. THE BROKEN FIBER AND PACKAGING WERE AVAILABLE TO SEND IN FOR INSPECTION. THE REPORTER ALSO INCLUDED THAT A HALF TREATMENT OF 250 SECONDS WAS FIRST PERFORMED ON THE PATIENT, THE LASER WAS PAUSED TO MOVE THE FIBER TO NEW LOCATION FOR ANOTHER 250 SECONDS (THERE WAS NO VISIBLE DAMAGE AT THIS TIME AS THE FIBER WAS TAKEN OUT OF THE SCOPE AND THEN REPOSITIONED IN THE UPPER LEFT LOBE - THE NEW POSITION). BECAUSE OF THIS, ONE CAN INFER THAT THE FRACTURE OF THE FIBER HAPPENED ON THE 2ND 250 SECOND TREATMENT. THE FURTHER PLAN FOR PHYSICIAN WAS TO TREAT THE PATIENT AGAIN ON MONDAY FOR HIS 2ND ILLUMINATION. PICTURES WERE SENT OF THE DAMAGED FIBER, BURN AREA IN THE UPPER LEFT LOBE AND THE PACKAGING. UPON FOLLOW-UP, PHYSICIAN CONFIRMED THAT PATIENT WAS STABLE WITH NO VISIBLE CONCERN AFTER THE PROCEDURE AND HE WAS MONITORED OVER THE WEEKEND WITH NO ISSUES AND TREATED AGAIN ON MONDAY, ON (B)(6) 2024 WITH A 3RD ILLUMINATION PLANNED FOR ON (B)(6) 2024. BROKEN FIBER WAS SHIPPED BACK TO QUALITY ON 26-NOV-2024 FOR INVESTIGATION. UPON RECEIVING QUALITY INVESTIGATION REPORT, COMPLAINT ANALYSIS CONFIRMED THAT PROXIMAL CONNECTOR END WAS IN GOOD CONDITION. DISTAL END WAS BROKEN WHERE THE SILVER RING CONNECTED TO THE DIFFUSER TIP. POSSIBLE CAUSES WERE DETERMINED AS POSSIBLE EXCESSIVE BENDING OF FIBER TIP IN ENDOSCOPE CAUSED FIBER TO KINK AND FRACTURE. LASER PERIPHERALS STRIVES TO MEET ALL CUSTOMER'S EXPECTATIONS AND NEEDS THROUGH 100% TESTING OF PRODUCT BEFORE IT LEAVES THE MANUFACTURING FACILITY. THEY CONSTANTLY TRY TO MAINTAIN AN ADHERENCE TO QUALITY AND THE SAFETY AND EFFICACY OF THE PRODUCTS. THEY UNDERSTAND THE INCONVENIENCE AND DIFFICULTIES THAT PROBLEMS IN THE FIELD CAN CAUSE. THEY HOPE THIS ANALYSIS HAS HELPED AND THEY ARE TAKING STEPS TO IMPROVE THEIR OWN PROCESSES. THE PATIENT'S TREATMENT MEDICATIONS AND LAB DATA WERE NOT REPORTED. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE EVENT AIRWAY BURNS WAS RESOLVED, AND OUTCOME OF EVENT DEVICE BREAKAGE WAS UNKNOWN. THE ACTION TAKEN WITH PHOTOFRIN WAS NO CHANGE. DE-CHALLENGE AND RE-CHALLENGE RESULT WERE NOT APPLICABLE WITH RESPECT TO PHOTOFRIN. THIS CASE IS CONSIDERED AS SERIOUS DUE TO SERIOUSNESS CRITERIA OTHER MEDICALLY IMPORTANT CONDITION AND INTERVENTION REQUIRED FOR THE EVENT AIRWAY BURNS AND EVENT DEVICE BREAKAGE IS CONSIDERED AS NON-SERIOUS. THE REPORTER CONSIDERED THE EVENTS AIRWAY BURNS AND DEVICE BREAKAGE TO BE POSSIBLY RELATED TO OPTIGUIDE FIBER OPTIC DIFFUSER AND 630 PDT LASER AND CONSIDERED EVENTS AIRWAY BURNS AND DEVICE BREAKAGE TO BE UNLIKELY RELATED TO PHOTOFRIN. CONSENT TO FOLLOW UP WITH THE REPORTER WAS GRANTED. CASE REVIEW PERFORMED ON 28-NOV-2024, THIS CASE WAS UPGRADED AS SERIOUS FROM NON-SERIOUS DUE TO SERIOUSNESS CRITERIA OTHER MEDICALLY IMPORTANT CONDITION AND INTERVENTION REQUIRED FOR THE EVENT AIRWAY BURNS. FOLLOW-UP INFORMATION WAS RECEIVED ON 26-NOV-2024: ADDITIONAL INFORMATION INCLUDED: PRIMARY REPORTER DETAILS WAS UPDATED, AND REPORTER TYPE WAS UPDATED AS PHYSICIAN. PATIENT'S AGE, DOSE AND ROUTE OF PHOTOFRIN ADDED. OUTCOME WAS UPDATED AS RESOLVED FOR EVENT AIRWAY BURNS. NARRATIVE AMENDED ACCORDINGLY. FOLLOW-UP INFORMATION WAS RECEIVED ON 04-DEC-2024 WITH QUALITY INVESTIGATION REPORT. ADDITIONAL INFORMATION INCLUDED: PQC INVESTIGATION RESULTS WERE ADDED IN OPTIGUIDE FIBER OPTIC DIFFUSER. REFERENCE NUMBER WAS ADDED. NARRATIVE AMENDED ACCORDINGLY. CASE COMMENTS: THE CASE IS ASSESSED AS SERIOUS AND UNLISTED AS PER THE COMPANY RSI. THE COMPANY CONSIDERED THE EVENTS OF AIRWAY BURNS, AND DEVICE BREAKAGE TO BE UNLIKELY RELATED TO PHOTOFRIN, AS PER WHO CAUSALITY CLASSIFICATION SYSTEM AS EVENTS REPORTED DEVICE. THE CASE IS ASSESSED AS SERIOUS AND UNLISTED AS PER THE COMPANY RSI. THE COMPANY CONSIDERED THE EVENT OF AIRWAY BURNS TO BE POSSIBLY RELATED TO OPTIGUIDE FIBER OPTIC DIFFUSER, AS PER WHO CAUSALITY CLASSIFICATION SYSTEM AS CONTRIBUTORY ROLE CANNOT BE EXCLUDED IN VIEW OF PLAUSIBLE TEMPORAL ASSOCIATION. THE COMPANY CONSIDERED THE EVENT OF DEVICE BREAKAGE TO BE POSSIBLY RELATED TO OPTIGUIDE FIBER OPTIC DIFFUSER, AS PER CONVENTION. THE CASE IS ASSESSED AS SERIOUS AND UNLISTED AS PER THE COMPANY RSI. THE COMPANY CONSIDERED THE EVENTS OF AIRWAY BURNS TO BE POSSIBLY RELATED TO 630 PDT LASER, AS PER WHO CAUSALITY CLASSIFICATION SYSTEM AS CONTRIBUTORY ROLE CANNOT BE EXCLUDED IN VIEW OF PLAUSIBLE TEMPORAL ASSOCIATION. THE COMPANY CONSIDERED THE EVENT OF DEVICE BREAKAGE TO BE POSSIBLY RELATED TO 630 PDT LASER, AS PER CONVENTION.

    Description of Event or Problem · 0

    THERE WAS A SMALL AREA WITHIN THE LEFT UPPER LOBE WHERE THE AIRWAY HAD BEEN CHARRED/BURNED BY THE BROKEN FIBER [AIRWAY BURNS] THERE WAS A SMALL AREA WITHIN THE LEFT UPPER LOBE WHERE THE AIRWAY HAD BEEN CHARRED/BURNED BY THE BROKEN FIBER [DEVICE BREAKAGE]. CASE NARRATIVE: CASE NUMBER (B)(4) IS A SPONTANEOUS REPORT RECEIVED FROM A PHYSICIAN VIA MEDICAL INFORMATION DEPARTMENT (B)(4) (REFERENCE ID: (B)(4)) ON (B)(6) 2024. THIS REPORT REFERS TO A 62-YEARS-OLD ADULT MALE PATIENT WHO HAD AIRWAY BURNS DUE TO DEVICE BREAKAGE (THERE WAS A SMALL AREA WITHIN THE LEFT UPPER LOBE WHERE THE AIRWAY HAD BEEN CHARRED/BURNED BY THE BROKEN FIBER) FOLLOWING TREATMENT WITH PHOTODYNAMIC THERAPY (PDT) (PHOTOFRIN, OPTIGUIDE FIBER OPTIC DIFFUSER, 630 PDT LASER). THE PATIENT'S MEDICAL HISTORY, HISTORICAL MEDICATION, CONCURRENT CONDITION, AND CONCOMITANT MEDICATION WERE NOT REPORTED. ON UNKNOWN DATE, THE PATIENT WAS STARTED ON PHOTOFRIN POWDER FOR SOLUTION FOR INJECTION AT A DOSE OF 2 MG/KG (3-5 MIN SLOW IV PUSH) VIA INTRAVENOUS ROUTE. IT WAS REPORTED THAT ON (B)(6) 2024 (APPROX. TIME WAS 12:55PM CT) DURING THE PDT PROCEDURE (1ST ILLUMINATION), 2.5 CM FLEX FIBER (LOT DG22053, EXPIRY DATE 25-AUG-2027) WAS VISIBLY BROKEN/FRACTURED ONCE REMOVED FROM THE PATIENT'S BODY CAVITY/LUNGS. THE ROOM NOTICED THE SMELL OF SOMETHING BURNING AND IMMEDIATELY TOOK THE FIBER OUT OF THE BODY CAVITY. THE LASER WAS SHUT OFF. UPON INSPECTION, THERE WAS A SMALL AREA WITHIN THE LEFT UPPER LOBE WHERE THE AIRWAY HAD BEEN CHARRED/BURNED BY THE BROKEN FIBER. AN AIRWAY INSPECTION OF THE BURNT LUNG TISSUE WAS DONE BY PHYSICIAN. IT WAS DECIDED TO TREAT WITH A NEW, 2.0CM FIBER IN THE SAME VICINITY FOR 180 MORE SECONDS AS IT WAS NOT ESTIMATING HOW MUCH TREATMENT WAS GIVEN IN THE AREA DUE TO THE FRACTURED FIBER. THERE WAS NO ISSUE WITH PREILLUMINATION USING THE 2CM RIGID FIBER AND NO MORE DAMAGE DONE TO THE AFFECTED AREA. THE AREA OF CONCERN SEEMED CONTAINED AND THERE WAS NO SIGN OF PERFORATION AT THE SITE. THE BROKEN FIBER AND PACKAGING WERE AVAILABLE TO SEND IN FOR INSPECTION. THE REPORTER ALSO INCLUDED THAT A HALF TREATMENT OF 250 SECONDS WAS FIRST PERFORMED ON THE PATIENT, THE LASER WAS PAUSED TO MOVE THE FIBER TO NEW LOCATION FOR ANOTHER 250 SECONDS (THERE WAS NO VISIBLE DAMAGE AT THIS TIME AS THE FIBER WAS TAKEN OUT OF THE SCOPE AND THEN REPOSITIONED IN THE UPPER LEFT LOBE - THE NEW POSITION). BECAUSE OF THIS, ONE CAN INFER THAT THE FRACTURE OF THE FIBER HAPPENED ON THE 2ND 250 SECOND TREATMENT. THE FURTHER PLAN FOR PHYSICIAN WAS TO TREAT THE PATIENT AGAIN ON MONDAY FOR HIS 2ND ILLUMINATION. PICTURES WERE SENT OF THE DAMAGED FIBER, BURN AREA IN THE UPPER LEFT LOBE AND THE PACKAGING. UPON FOLLOW-UP, PHYSICIAN CONFIRMED THAT PATIENT WAS STABLE WITH NO VISIBLE CONCERN AFTER THE PROCEDURE AND HE WAS MONITORED OVER THE WEEKEND WITH NO ISSUES AND TREATED AGAIN ON MONDAY, (B)(6) 2024 WITH A 3RD ILLUMINATION PLANNED FOR (B)(6) 2024. BROKEN FIBER WAS SHIPPED BACK TO QUALITY ON (B)(6) 2024 FOR INVESTIGATION. UPON RECEIVING QUALITY INVESTIGATION REPORT, COMPLAINT ANALYSIS CONFIRMED THAT PROXIMAL CONNECTOR END WAS IN GOOD CONDITION. DISTAL END WAS BROKEN WHERE THE SILVER RING CONNECTED TO THE DIFFUSER TIP. POSSIBLE CAUSES WERE DETERMINED AS POSSIBLE EXCESSIVE BENDING OF FIBER TIP IN ENDOSCOPE CAUSED FIBER TO KINK AND FRACTURE. LASER PERIPHERALS STRIVES TO MEET ALL CUSTOMER'S EXPECTATIONS AND NEEDS THROUGH 100% TESTING OF PRODUCT BEFORE IT LEAVES THE MANUFACTURING FACILITY. THEY CONSTANTLY TRY TO MAINTAIN AN ADHERENCE TO QUALITY AND THE SAFETY AND EFFICACY OF THE PRODUCTS. THEY UNDERSTAND THE INCONVENIENCE AND DIFFICULTIES THAT PROBLEMS IN THE FIELD CAN CAUSE. THEY HOPE THIS ANALYSIS HAS HELPED AND THEY ARE TAKING STEPS TO IMPROVE THEIR OWN PROCESSES. THE PATIENT'S TREATMENT MEDICATIONS AND LAB DATA WERE NOT REPORTED. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE EVENT AIRWAY BURNS WAS RESOLVED, AND OUTCOME OF EVENT DEVICE BREAKAGE WAS UNKNOWN. THE ACTION TAKEN WITH PHOTOFRIN WAS NO CHANGE. DE-CHALLENGE AND RE-CHALLENGE RESULT WERE NOT APPLICABLE WITH RESPECT TO PHOTOFRIN. THIS CASE IS CONSIDERED AS SERIOUS DUE TO SERIOUSNESS CRITERIA OTHER MEDICALLY IMPORTANT CONDITION AND INTERVENTION REQUIRED FOR THE EVENT AIRWAY BURNS AND EVENT DEVICE BREAKAGE IS CONSIDERED AS NON-SERIOUS. THE REPORTER CONSIDERED THE EVENTS AIRWAY BURNS AND DEVICE BREAKAGE TO BE POSSIBLY RELATED TO OPTIGUIDE FIBER OPTIC DIFFUSER. HOWEVER, CONSIDERED EVENTS AIRWAY BURNS AND DEVICE BREAKAGE TO BE UNLIKELY RELATED TO PHOTOFRIN AND 630 PDT LASER. CONSENT TO FOLLOW UP WITH THE REPORTER WAS GRANTED. CASE REVIEW PERFORMED ON (B)(6) 2024, THIS CASE WAS UPGRADED AS SERIOUS FROM NON-SERIOUS DUE TO SERIOUSNESS CRITERIA OTHER MEDICALLY IMPORTANT CONDITION AND INTERVENTION REQUIRED FOR THE EVENT AIRWAY BURNS. FOLLOW-UP INFORMATION WAS RECEIVED ON 26-NOV-2024: ADDITIONAL INFORMATION INCLUDED: PRIMARY REPORTER DETAILS WAS UPDATED, AND REPORTER TYPE WAS UPDATED AS PHYSICIAN. PATIENT'S AGE, DOSE AND ROUTE OF PHOTOFRIN ADDED. OUTCOME WAS UPDATED AS RESOLVED FOR EVENT AIRWAY BURNS. NARRATIVE AMENDED ACCORDINGLY. FOLLOW-UP INFORMATION WAS RECEIVED ON 04-DEC-2024 WITH QUALITY INVESTIGATION REPORT. ADDITIONAL INFORMATION INCLUDED: PQC INVESTIGATION RESULTS WERE ADDED IN OPTIGUIDE FIBER OPTIC DIFFUSER. REFERENCE NUMBER WAS ADDED. NARRATIVE AMENDED ACCORDINGLY. FOLLOW-UP INFORMATION WAS RECEIVED ON 14-MAY-2025 VIA MEDICAL INFORMATION DEPARTMENT. THEY PERFORMED THE FOLLOW UP BY TELEPHONE ON 14-MAY-2025 AND THE ENQUIRER DID NOT PICK UP. CASE REVIEW PERFORMED ON (B)(6) 2025, THE REPORTER AND COMPANY CAUSALITY FOR 630 PDT LASER WITH EVENTS AIRWAY BURNS AND DEVICE BREAKAGE WAS UPDATED TO UNLIKELY RELATED AS THE EVENT AIRWAY BURNS OCCURRED DUE TO BREAKAGE OF THE OPTIGUIDE FIBER OPTIC DIFFUSER. CASE COMMENTS: THE CASE IS ASSESSED AS SERIOUS AND UNLISTED AS PER THE COMPANY RSI. THE COMPANY CONSIDERED THE EVENTS OF AIRWAY BURNS, AND DEVICE BREAKAGE TO BE UNLIKELY RELATED TO PHOTOFRIN, AS PER WHO CAUSALITY CLASSIFICATION SYSTEM AS EVENTS ARE CAUSED DUE TO BREAKAGE OF THE OPTIGUIDE FIBER OPTIC DIFFUSER AND CONTRIBUTORY ROLE OF DRUG CANNOT BE ESTABLISHED. THE CASE IS ASSESSED AS SERIOUS AND UNLISTED AS PER THE COMPANY RSI. THE COMPANY CONSIDERED THE EVENT OF AIRWAY BURNS TO BE POSSIBLY RELATED TO OPTIGUIDE FIBER OPTIC DIFFUSER, AS PER WHO CAUSALITY CLASSIFICATION SYSTEM AS CONTRIBUTORY ROLE CANNOT BE EXCLUDED IN VIEW OF PLAUSIBLE TEMPORAL ASSOCIATION WITH THE BROKEN FIBER. THE COMPANY CONSIDERED THE EVENT OF DEVICE BREAKAGE TO BE POSSIBLY RELATED TO OPTIGUIDE FIBER OPTIC DIFFUSER, AND AS PER THE INVESTIGATION REPORT, THE POSSIBLE CAUSES WERE DETERMINED AS POSSIBLE EXCESSIVE BENDING OF FIBER TIP IN ENDOSCOPE WHICH CAUSED THE FIBER TO KINK AND FRACTURE. THE CASE IS ASSESSED AS SERIOUS AND UNLISTED AS PER THE COMPANY RSI. THE COMPANY CONSIDERED THE EVENTS OF AIRWAY BURNS AND DEVICE BREAKAGE TO BE UNLIKELY RELATED TO 630 PDT LASER, AS PER WHO CAUSALITY CLASSIFICATION SYSTEM AS THE EVENTS OCCURRED DUE TO BREAKAGE OF THE OPTIGUIDE FIBER OPTIC DIFFUSER AND CONTRIBUTORY ROLE OF 630 PDT LASER CANNOT BE ESTABLISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2512041 OPTIGUIDE FIBER OPTIC DIFFUSER FIBER MVG 00376128000377 DG22053

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other| R