Description of Event or Problem · 1
ON 18-MAY-2021, A PINNACLE BIOLOGICS PDT (PHOTODYNAMIC THERAPY) SPECIALIST REPORTED A LASER DIFFUSER FIBER 'MELTED' DURING A PROCEDURE FOR AN UNKNOWN INDICATION. THE PATIENT WAS TREATED WITH THE DIOMED OPTIGUIDE FIBER OPTIC DIFFUSER (2.5 CM FLEXIBLE FIBER). AN INTERVENTIONAL PULMONOLOGIST WAS PERFORMING THE PROCEDURE TO TREAT THE RIGHT UPPER LOBE. THE FIBER MELTED DURING THE BRONCHOSCOPY. AT 130 SECONDS INTO THE TREATMENT, THERE WAS SMOKE IN THE AIRWAY AND THE TREATMENT WAS STOPPED; THE FIBER WAS PULLED OUT. THERE APPEARED TO BE SOME CHARRING OF BLOOD AND A PORTION OF THE FIBER HAD MELTED. THE PATIENT DID NOT EXHIBIT ANY ADVERSE AFFECT. THE PDT SPECIALIST RECOVERED THE DISCARDED PB725 2.5CM CYLINDRICAL DIFFUSER (LOT #DG19017) FROM THE WASTE AREA, THEREFORE ALLOWING THE MANUFACTURER TO INDEPENDENTLY EVALUATE THE DISCARDED FIBER AND REPORT THEIR INVESTIGATION FINDINGS TO PINNACLE BIOLOGICS. BASED ON THE MANUFACTURER'S PRODUCT KNOWLEDGE, IT WAS THEIR CONCLUSION THE FIBER WAS LIKELY BENT (KINKED) DURING INSERTION INTO THE PATIENT PRIOR TO THE LASER FIRING AND ONCE THE LASER WAS FIRED, THE KINK CAUSED A CONCENTRATION OF THE LASER'S ENERGY AT THE JUNCTION, THEREBY CAUSING A THERMAL DISCHARGE. THE PINNACLE PDT SPECIALIST PHOTOGRAPHED THE DISCARDED FIBER PRIOR TO SHIPMENT TO THE FIBER MANUFACTURER IN WHICH IT IS EVIDENT THE THERMAL DISCHARGE WAS LOCATED ALONG THE LENGTH OF THE FIBER AND NOT ON THE DIFFUSER TIP. THE MANUFACTURER'S COMPLAINT RESPONSE FURTHER CONFIRMS THE PROXIMAL CONNECTOR END OF THE DIFFUSER TIP WAS IN GOOD CONDITION. AS AN OUTCOME OF THIS INVESTIGATION, PINNACLE BIOLOGICS CAN CONCLUDE THE THERMAL DISCHARGE WAS CAUSED BY THE INSERTION PROCESS, AND NOT AS A RESULT OF A DEFECTIVE DEVICE. FURTHER, THERE IS NO INDICATION THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS AS A RESULT OF THIS INCIDENT AND THE REPORT IS CONSIDERED CLOSED. THIS CASE CORRESPONDS TO THE FOLLOWING PINNACLE BIOLOGICS INC. ICSR#: (B)(4).