MAUDE Adverse Event Report: PINNACLE BIOLOGICS INC PHOTOFRIN 630 PDT LASER; SYSTEM, LASER, PHOTODYNAMIC THERAPY

Catalog Number 63001

Device Problem Failure to Calibrate (2440)

Patient Problems Awareness during Anaesthesia (1707); Ventilator Dependent (2395)

Event Date 11/21/2016

Event Type  Injury  

Manufacturer Narrative

A physician reported to the medical science liaison on (b)(6) 2016 that an elderly male patient of unknown age experienced being under anesthesia longer than he should have, ended up having to go to the intensive care unit on the ventilator after the pdt and the fibers weren't calibrating after administration of photofrin (portimer sodium) for esophageal cancer and co-suspect device's photofrin 630 pdt laser (serial number (b)(4)) for the esophageal pdt treatment.This is 2 of 2 reports received from the same reporter [(b)(6) (3010119152-2017-00001)].The patient's significant past medical history included a bad heart.No other information was provided regarding the patient's medical history, concurrent conditions, or other concomitant medications.On an unknown date, the patient started photofrin (portimer sodium) for an unknown indication and co-suspect device's photofrin 630 pdt laser (serial number (b)(4)) for the esophageal pdt treatment.On (b)(4) 2016, the patient experienced under anesthesia longer than he should have because the fibers were not calibrating.The patient ended up having to go to the intensive care unit on the ventilator after the pdt case on (b)(6) 2016.Two lasers ( (b)(4)) were successfully calibrated (with multiple attempts) the dcyl 210, 710, 725, 750, however, both lasers failed calibration (with multiple attempts) for the dcyl 225, 250.Both lasers also put out too much power (see relevant laboratory tests), with laser (serial number (b)(4)) putting out the highest power at a not acceptable level.The reporter stated that some of the fibers failed.The cuvette in the lasers was switched out for a different cuvette (a cleaner appearing cuvette), the first laser (serial number (b)(4)) passed calibration with dcyl 225 and 250, and put out more accurate power (dcyl 710 power output went from 129% to 106% with new cuvette).The same new cuvette was placed into the second laser (serial number (b)(4)), it passed calibration dcyl 225, but still failed calibration dcyl 250.Additional information was received on 10-dec-2016 from a company representative.The following additional information was obtained.The patient was confirmed to have recovered and was released from the icu.Additional information was received on 10-jan-2016 from a company representative.The following information was obtained.It was confirmed that an on-site investigation of the products took place on 30-nov-2016 to 01-dec-2016.Both products ((b)(4)) failed to calibrate (calibration percentage 61-62 % and 64-65 % with systems (b)(4), respectively).It was confirmed by the reporter that the reported findings by the customer were verified.Device (b)(4) was also tested with a new cuvette and it failed to calibrate using dcyl250 fiber indicating a transmittance of 69 %, which is just below the specified acceptable transmission range of 70-99 %.The device functioned in a safe way i.E.Preventing the calibration when the light transmission is out of the specified range and the calibration in such a case could have resulted in incorrect light dose.The calibration failure state is also addressed in the operator's / user manual (section 5.7.4 calibration) and is in fact a safety measure of the device.With a new cuvette, both devices calibrated successfully with a dcyl225 fiber with power max.16 % higher than the target value.This demonstrated that the devices were functional when excess losses were removed and a new cuvette was used during the calibration.Eqid174 was used to measure output power from the application fibers.The investigations also showed the sensitivity to the external factors due to the specified calibration procedure using different fiber types with the same calibration factors.Due to the close-to-the-specification limit measurement values of the calibrated power, recalibration/fine-tuning of the power calibration factors (sphere and laser module) was done for these the 2 units ( (b)(4)).When following the specified calibration procedure, the device needs to handle different fiber types with significant differences in losses and response factors in the calibration port.This means that the window at which the calibration passes becomes in practice more limited than 70-99 % and the device is more sensitive to the external conditions / factors such fiber-to-fiber loss variation, cuvette condition, fiber positioning in the calibration port during calibration etc.These effects were concluded to have caused the calibration to fail for device 684614 with a dcyl250 fiber.The impact of removal of the cuvette during the calibration was investigated at modulight factory using another device ((b)(4)).By default the calibration port response is assumed to be higher without a cuvette and therefore the calibrated power is expected to be lower than when using a cuvette during the calibration.The calibration tests without a cuvette in place were in line with this assumption.Therefore, it was concluded that it is unlikely that the treatment power and dose would have been excessive.The results indicate that it is likely that the dose has been within the correct range.The investigation on the calibration without a cuvette indicate that is not likely that during the treatment the dosing would have been out of the specification and no harm for the patient is expected.In the operator's manual / user manual page 32 (5.7.4 calibration, ml7710-630-pin user manual page 32) the cuvette must be used during the calibration as the device has been calibrated with a cuvette and therefore the removal of the cause unnecessary uncertainty to the treatment dose.The outcome of under anesthesia longer than he should have, ended up having to go to the intensive care unit on the ventilator after the pdt and the fibers weren't calibrating is recovered.

Event Description

A physician reported to the medical science liaison on (b)(6) 2016 that an elderly male patient of unknown age experienced being under anesthesia longer than he should have, ended up having to go to the intensive care unit on the ventilator after the pdt and the fibers weren't calibrating after administration of photofrin (portimer sodium) for esophageal cancer and co-suspect device's photofrin 630 pdt laser (serial number (b)(4)) for the esophageal pdt treatment.This is 2 of 2 reports received from the same reporter [(b)(6) (3010119152-2017-00001)].The patient's significant past medical history included a bad heart.No other information was provided regarding the patient's medical history, concurrent conditions, or other concomitant medications.On an unknown date, the patient started photofrin (portimer sodium) for an unknown indication and co-suspect device's photofrin 630 pdt laser (serial number (b)(4)) for the esophageal pdt treatment.On (b)(6) 2016, the patient experienced under anesthesia longer than he should have because the fibers were not calibrating.The patient ended up having to go to the intensive care unit on the ventilator after the pdt case on (b)(6) 2016.Two lasers (684613 and 684614) were successfully calibrated (with multiple attempts) the dcyl 210, 710, 725, 750, however, both lasers failed calibration (with multiple attempts) for the dcyl 225, 250.Both lasers also put out too much power (see relevant laboratory tests), with laser (serial number (b)(4)) putting out the highest power at a not acceptable level.The reporter stated that some of the fibers failed.The cuvette in the lasers was switched out for a different cuvette (a cleaner appearing cuvette), the first laser (serial number (b)(4)) passed calibration with dcyl 225 and 250, and put out more accurate power (dcyl 710 power output went from 129% to 106% with new cuvette).The same new cuvette was placed into the second laser (serial number (b)(4)), it passed calibration dcyl 225, but still failed calibration dcyl 250.Additional information was received on 10-dec-2016 from a company representative.The following additional information was obtained.The patient was confirmed to have recovered and was released from the icu.Additional information was received on 10-jan-2016 from a company representative.The following information was obtained.It was confirmed that an on-site investigation of the products took place on 30-nov-2016 to 01-dec-2016.Both products ((b)(4)) failed to calibrate (calibration percentage 61-62 % and 64-65 % with systems (b)(4), respectively).It was confirmed by the reporter that the reported findings by the customer were verified.Device (b)(4) was also tested with a new cuvette and it failed to calibrate using dcyl250 fiber indicating a transmittance of 69 %, which is just below the specified acceptable transmission range of 70-99 %.The device functioned in a safe way i.E.Preventing the calibration when the light transmission is out of the specified range and the calibration in such a case could have resulted in incorrect light dose.The calibration failure state is also addressed in the operator's / user manual (section 5.7.4 calibration) and is in fact a safety measure of the device.With a new cuvette, both devices calibrated successfully with a dcyl225 fiber with power max.16 % higher than the target value.This demonstrated that the devices were functional when excess losses were removed and a new cuvette was used during the calibration.Eqid174 was used to measure output power from the application fibers.The investigations also showed the sensitivity to the external factors due to the specified calibration procedure using different fiber types with the same calibration factors.Due to the close-to-the-specification limit measurement values of the calibrated power, recalibration/fine-tuning of the power calibration factors (sphere and laser module) was done for these the 2 units ((b)(4)).When following the specified calibration procedure, the device needs to handle different fiber types with significant differences in losses and response factors in the calibration port.This means that the window at which the calibration passes becomes in practice more limited than 70-99 % and the device is more sensitive to the external conditions / factors such fiber-to-fiber loss variation, cuvette condition, fiber positioning in the calibration port during calibration etc.These effects were concluded to have caused the calibration to fail for device (b)(4) with a dcyl250 fiber.The impact of removal of the cuvette during the calibration was investigated at modulight factory using another device ((b)(4)).By default the calibration port response is assumed to be higher without a cuvette and therefore the calibrated power is expected to be lower than when using a cuvette during the calibration.The calibration tests without a cuvette in place were in line with this assumption.Therefore, it was concluded that it is unlikely that the treatment power and dose would have been excessive.The results indicate that it is likely that the dose has been within the correct range.The investigation on the calibration without a cuvette indicate that is not likely that during the treatment the dosing would have been out of the specification and no harm for the patient is expected.In the operator's manual / user manual page 32 (5.7.4 calibration, ml7710-630-pin user manual page 32) the cuvette must be used during the calibration as the device has been calibrated with a cuvette and therefore the removal of the cause unnecessary uncertainty to the treatment dose.The outcome of under anesthesia longer than he should have, ended up having to go to the intensive care unit on the ventilator after the pdt and the fibers weren't calibrating is recovered.

• Brand Name: PHOTOFRIN 630 PDT LASER
• Type of Device: SYSTEM, LASER, PHOTODYNAMIC THERAPY
• Manufacturer (Section D): PINNACLE BIOLOGICS INC; 311 s. wacker drive, suite 499; chicago IL 60606
• Manufacturer (Section G): MODULIGHT, INC; hermiankatu 22; tampere, lansi-suomen laani 33720 ; FI 33720
• Manufacturer Contact: lori hays ; 311 s. wacker drive; suite 4990; chicago, IL 60606 ; 7732190757
• MDR Report Key: 6259767
• MDR Text Key: 65048612
• Report Number: 3010119152-2017-00001
• Device Sequence Number: 1
• Product Code: MVF
• Combination Product (y/n): N
• PMA/PMN Number: P990021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 63001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OPTIGUIDE FIBER OPTIC DIFFUSER; PHOTOFRIN (PORFIMER SODIUM)
• Patient Outcome(s): Hospitalization; Life Threatening; Other