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 (ADVANZ PHARMA) (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 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, (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. 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 (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. CASE COMMENTS: THE CASE IS ASSESSED AS NON-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 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 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.