BEUDAMED
    FDA Adverse Event Injury Summary report: N

    630 PDT LASER

    MDR report key: 11462255 · Received March 11, 2021

    Report

    Report Number
    3010119152-2021-00001
    Event Type
    Injury
    Date Received
    March 11, 2021
    Report Date
    May 13, 2021
    Manufacturer
    PINNACLE BIOLOGICS, INC.
    Product Code
    MVF
    PMA / PMN Number
    P990021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED FROM A PDT SPECIALIST AT PINNACLE BIOLOGICS INC. ON 12-FEB-2021. THIS CASE IS RELATED TO 3010119152-2021-00002 AND 3010119152-2021-00003 (SAME REPORTER). A NURSE ANESTHETIST REPORTED ON 10-FEB-2021 THAT A PATIENT OF UNSPECIFIED AGE AND GENDER EXPERIENCED A BLOOD PRESSURE DROP AFTER THEY UNDERWENT LIGHT APPLICATION USING THE DIOMED 630 PDT LASER AND THE DIOMED OPTIGUIDE FIBER OPTIC DIFFUSER FOR AN UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT RECEIVED PHOTOFRIN (PORFIRMER SODIUM) PDT AT UNKNOWN DOSAGE FOR AN UNKNOWN INDICATION (SITE: MIDMICHIGAN MEDICAL CENTER, 4000 WELLNESS DRIVE, MIDLAND, MI). ON AN UNKNOWN DATE, THE PATIENT UNDERWENT LIGHT APPLICATION USING THE DIOMED 630 PDT LASER AND THE DIOMED OPTIGUIDE FIBER OPTIC DIFFUSER. THE PATIENT'S BLOOD PRESSURE DROPED WHEN TURNING THE LASER ON. THE BLOOD PRESSURE DROP WAS SIGNIFICANT, AT ABOUT 40-50%. THE LAST COUPLE OF TIMES THEY ILLUMINATED, THE NURSE ANESTHETIST HAD AN ARTERIAL LINE INJECTED IN THE PATIENT'S WRIST INSTEAD OF JUST AN INFLATABLE PAD PLACED AROUND ARM. THIS WAS SO THE NURSE ANESTHETIST COULD DO A LIVE, CONTINUOUS PRESSURE MONITORING. THE NURSE ANESTHETIST ALSO HAD EPHEDRINE AND PHENYLEPHRINE SHOTS READY, TO GET THE PRESSURE BACK TO NORMAL LEVELS. THE OUTCOME OF THE EVENT WAS NOT REPORTED. THE REPORTER ASSESSED THE CAUSAL RELATIONSHIP OF THE EVENT AS POSSIBLY RELATED TO THE USE OF LIGHT APPLICATION. FOLLOW-UP #1 ADDITIONAL INFORMATION WAS RECEIVED FROM PINNACLE BIOLOGICS INC. QUALITY ASSURANCE (QA) IN THE FORM OF AN INVESTIGATION REPORT ON 16-APR-2021. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE PATIENT WAS A 65 YEAR-OLD MALE DIAGNOSED WITH NON-SMALL CELL LUNG CANCER AND CONCURRENTLY DIAGNOSED WITH ACCUTE RESPIRATORY FAILURE, DIABETES, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), PULMONARY FIBROSIS. PER PINNACLE BIOLOGICS INC. QA, IN REVIEWING INFORMATION COMMUNICATED TO THE PINNACLE PDT SPECIALIST ON FEBRUARY 10, 2021, IT WAS CONCLUDED THIS WAS AN INFORMAL CONVERSATION BETWEEN A CLINICIAN AT THE MIDMICHIGAN MEDICAL CENTER WHO MAY OR MAY NOT HAVE BEEN DIRECTLY INVOLVED IN THE TREATMENT OF THE UNKNOWN PATIENT, ON AN UNKNOWN DATE AND FOR AN UNKNOWN INDICATION AS DOCUMENTED IN MEDWATCH REPORT 3010119152-2021-00001. THERE WAS NO INDICATION THE NURSE ANESTHETIST OR ANY OTHER CLINICIAN OR MEDICAL PROFESSIONAL INVOLVED WITH THE UNIDENTIFIED PATIENT WAS REQUIRED TO PROVIDE ANY UNPLANNED TREATMENT OR RESPONSE ACTIVITY FOLLOWING THE LIGHT ACTIVATION USING THE DIOMED 630 PDT LASER AND OPTIGUIDE FIBER OPTIC DIFFUSER. ADDITIONAL INFORMATION RECEIVED FROM THE NURSE ANESTHETIST ON APRIL 01, 2021 DID NOT FURTHER SUPPORT THAT ANY POTENTIAL TREATMENT SIDE EFFECT OR REPORTABLE ADVERSE EVENT COULD BE ATTRIBUTED TO LIGHT ACTIVATION USING THE DIOMED 630 PDT LASER AND OPTIGUIDE FIBER OPTIC DIFFUSER. AS STATED BY THE REPORTER IN THE EMAIL RESPONSE OF MARCH 05, 2021, THE REPORTER WAS INQUIRING "IF THIS WAS SOMETHING THAT WAS NOTICED AT OTHER INSTITUTIONS", SUGGESTING THIS WAS NOT INTENDED AS AN ADVERSE EVENT REPORT, BUT MERELY AS INFORMATION SEEKING ON THE PART OF THE REPORTER. THE INTERNAL REVIEW OF CUSTOMER COMPLAINTS, ADVERSE EVENTS, INTERNALLY GENERATED CAPAS AND MANAGEMENT REVIEW REPORTS FROM 2018 THROUGH THE PRESENT DID NOT YIELD ANY EVIDENCE THAT A PATIENT'S DROP IN BLOOD PRESSURE HAD BEEN PREVIOUSLY BEEN REPORTED IN ASSOCIATION WITH THE LIGHT ACTIVATION USING THE DIOMED 630 PDT LASER AND OPTIGUIDE FIBER OPTIC DIFFUSER OR DURING ANY PORTION OF THE PHOTOFRIN (PORFIMER SODIUM) THERAPY, DRUG DELIVERY OR DEVICE ACTIVATION REGIME. IN CONCLUSION, PINNACLE BIOLOGICS CANNOT VERIFY THAT THE LIGHT ACTIVATION USING THE DIORNED 630 PDT LASER AND OPTIGUIDE FIBER OPTIC DIFFUSER WAS A POTENTIAL OR ACTUAL CAUSE OF THE REPORTED EVENT AND THIS INVESTIGATION INTO MEDWATCH REPORT 3010119152-2021-00001 IS CONSIDERED CLOSED. THIS CASE CORRESPONDS TO THE FOLLOWING PINNACLE BIOLOGICS INC. ICSR#: (B)(4).

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED FROM A PDT SPECIALIST AT PINNACLE BIOLOGICS INC. ON 12-FEB-2021. THIS CASE IS RELATED TO 3010119152-2021-00002 AND 3010119152-2021-00003 (SAME REPORTER). A NURSE ANESTHETIST REPORTED ON 10-FEB-2021 THAT A PATIENT OF UNSPECIFIED AGE AND GENDER EXPERIENCED A BLOOD PRESSURE DROP AFTER THEY UNDERWENT LIGHT APPLICATION USING THE DIOMED 630 PDT LASER AND THE DIOMED OPTIGUIDE FIBER OPTIC DIFFUSER FOR AN UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT RECEIVED PHOTOFRIN (PORFIRMER SODIUM) PDT AT UNKNOWN DOSAGE FOR AN UNKNOWN INDICATION (SITE: (B)(6) MEDICAL CENTER). ON AN UNKNOWN DATE, THE PATIENT UNDERWENT LIGHT APPLICATION USING THE DIOMED 630 PDT LASER AND THE DIOMED OPTIGUIDE FIBER OPTIC DIFFUSER. THE PATIENT'S BLOOD PRESSURE DROPED WHEN TURNING THE LASER ON. THE BLOOD PRESSURE DROP WAS SIGNIFICANT, AT ABOUT 40-50%. THE LAST COUPLE OF TIMES THEY ILLUMINATED, THE NURSE ANESTHETIST HAD AN ARTERIAL LINE INJECTED IN THE PATIENT'S WRIST INSTEAD OF JUST AN INFLATABLE PAD PLACED AROUND ARM. THIS WAS SO THE NURSE ANESTHETIST COULD DO A LIVE, CONTINUOUS PRESSURE MONITORING. THE NURSE ANESTHETIST ALSO HAD EPHEDRINE AND PHENYLEPHRINE SHOTS READY, TO GET THE PRESSURE BACK TO NORMAL LEVELS. THE OUTCOME OF THE EVENT WAS NOT REPORTED. THE REPORTER ASSESSED THE CAUSAL RELATIONSHIP OF THE EVENT AS POSSIBLY RELATED TO THE USE OF LIGHT APPLICATION. FOLLOW-UP #1: ADDITIONAL INFORMATION WAS RECEIVED FROM PINNACLE BIOLOGICS INC. QUALITY ASSURANCE (QA) IN THE FORM OF AN INVESTIGATION REPORT ON 16-APR-2021. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE PATIENT WAS A 65 YEAR-OLD MALE DIAGNOSED WITH NON-SMALL CELL LUNG CANCER AND CONCURRENTLY DIAGNOSED WITH ACCUTE RESPIRATORY FAILURE, DIABETES, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), PULMONARY FIBROSIS. PER PINNACLE BIOLOGICS INC. QA, IN REVIEWING INFORMATION COMMUNICATED TO THE PINNACLE PDT SPECIALIST ON FEBRUARY 10, 2021, IT WAS CONCLUDED THIS WAS AN INFORMAL CONVERSATION BETWEEN A CLINICIAN AT THE MIDMICHIGAN MEDICAL CENTER WHO MAY OR MAY NOT HAVE BEEN DIRECTLY INVOLVED IN THE TREATMENT OF THE UNKNOWN PATIENT, ON AN UNKNOWN DATE AND FOR AN UNKNOWN INDICATION AS DOCUMENTED IN MEDWATCH REPORT 3010119152-2021-00001. THERE WAS NO INDICATION THE NURSE ANESTHETIST OR ANY OTHER CLINICIAN OR MEDICAL PROFESSIONAL INVOLVED WITH THE UNIDENTIFIED PATIENT WAS REQUIRED TO PROVIDE ANY UNPLANNED TREATMENT OR RESPONSE ACTIVITY FOLLOWING THE LIGHT ACTIVATION USING THE DIOMED 630 PDT LASER AND OPTIGUIDE FIBER OPTIC DIFFUSER. ADDITIONAL INFORMATION RECEIVED FROM THE NURSE ANESTHETIST ON APRIL 01, 2021 DID NOT FURTHER SUPPORT THAT ANY POTENTIAL TREATMENT SIDE EFFECT OR REPORTABLE ADVERSE EVENT COULD BE ATTRIBUTED TO LIGHT ACTIVATION USING THE DIOMED 630 PDT LASER AND OPTIGUIDE FIBER OPTIC DIFFUSER. AS STATED BY THE REPORTER IN THE EMAIL RESPONSE OF MARCH 05, 2021, THE REPORTER WAS INQUIRING "IF THIS WAS SOMETHING THAT WAS NOTICED AT OTHER INSTITUTIONS", SUGGESTING THIS WAS NOT INTENDED AS AN ADVERSE EVENT REPORT, BUT MERELY AS INFORMATION SEEKING ON THE PART OF THE REPORTER. THE INTERNAL REVIEW OF CUSTOMER COMPLAINTS, ADVERSE EVENTS, INTERNALLY GENERATED CAPAS AND MANAGEMENT REVIEW REPORTS FROM 2018 THROUGH THE PRESENT DID NOT YIELD ANY EVIDENCE THAT A PATIENT'S DROP IN BLOOD PRESSURE HAD BEEN PREVIOUSLY BEEN REPORTED IN ASSOCIATION WITH THE LIGHT ACTIVATION USING THE DIOMED 630 PDT LASER AND OPTIGUIDE FIBER OPTIC DIFFUSER OR DURING ANY PORTION OF THE PHOTOFRIN (PORFIMER SODIUM) THERAPY, DRUG DELIVERY OR DEVICE ACTIVATION REGIME. IN CONCLUSION, PINNACLE BIOLOGICS CANNOT VERIFY THAT THE LIGHT ACTIVATION USING THE DIORNED 630 PDT LASER AND OPTIGUIDE FIBER OPTIC DIFFUSER WAS A POTENTIAL OR ACTUAL CAUSE OF THE REPORTED EVENT AND THIS INVESTIGATION INTO MEDWATCH REPORT 3010119152-2021-00001 IS CONSIDERED CLOSED. THIS CASE CORRESPONDS TO THE FOLLOWING PINNACLE BIOLOGICS INC. ICSR#: (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A PDT SPECIALIST AT PINNACLE BIOLOGICS INC. ON 12-FEB-2021. THIS CASE IS RELATED TO 3010119152-2021-00002 AND 3010119152-2021-00003 (SAME REPORTER). A NURSE ANESTHETIST REPORTED ON 10-FEB-2021 THAT A PATIENT OF UNSPECIFIED AGE AND GENDER EXPERIENCED A BLOOD PRESSURE DROP AFTER THEY UNDERWENT LIGHT APPLICATION USING THE DIOMED 630 PDT LASER AND THE DIOMED OPTIGUIDE FIBER OPTIC DIFFUSER FOR AN UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT RECEIVED PHOTOFRIN (PORFIRMER SODIUM) PDT AT UNKNOWN DOSAGE FOR AN UNKNOWN INDICATION (SITE: (B)(6) MEDICAL CENTER, (B)(6)). ON AN UNKNOWN DATE, THE PATIENT UNDERWENT LIGHT APPLICATION USING THE DIOMED 630 PDT LASER AND THE DIOMED OPTIGUIDE FIBER OPTIC DIFFUSER. THE PATIENT'S BLOOD PRESSURE DROPPED WHEN TURNING THE LASER ON. THE BLOOD PRESSURE DROP WAS SIGNIFICANT, AT ABOUT 40-50%. THE LAST COUPLE OF TIMES THEY ILLUMINATED, THE NURSE ANESTHETIST HAD AN ARTERIAL LINE INJECTED IN THE PATIENT'S WRIST INSTEAD OF JUST AN INFLATABLE PAD PLACED AROUND ARM. THIS WAS SO THE NURSE ANESTHETIST COULD DO A LIVE, CONTINUOUS PRESSURE MONITORING. THE NURSE ANESTHETIST ALSO HAD EPHEDRINE AND PHENYLEPHRINE SHOTS READY, TO GET THE PRESSURE BACK TO NORMAL LEVELS. NO FURTHER INFORMATION WAS PROVIDED. THE OUTCOME OF THE EVENT WAS NOT REPORTED. THE REPORTER ASSESSED THE CAUSAL RELATIONSHIP OF THE EVENT AS POSSIBLY RELATED TO THE USE OF LIGHT APPLICATION. THIS CASE CORRESPONDS TO THE FOLLOWING PINNACLE BIOLOGICS INC. ICSR#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361835 630 PDT LASER SYSTEM, LASER, PHOTODYNAMIC THERAPY MVF PINNACLE BIOLOGICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other OPTIGUIDE FIBER OPTIC DIFFUSER| OPTIGUIDE FIBER OPTIC DIFFUSER| OPTIGUIDE FIBER OPTIC DIFFUSER| PHOTOFRIN (PORFIRMER SODIUM) FOR INJECTION| PHOTOFRIN (PORFIRMER SODIUM) FOR INJECTION| PHOTOFRIN (PORFIRMER SODIUM) FOR INJECTION