MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN PLANNING SOFTWARE APPLICATION

Model Number	SFT-0010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Missing Value Reason (3192)
Date of Event	07/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) 2020: physician scheduled a patient for navigational bronchoscopy w/ ebus.Patient received same day ct scan, and cd was burned to be imported into planning station.While importing data the physician reviewed ct on isight desktop at hospital.While waiting for disk to finish burning, patient was brought into procedure room, and at this time it had been 20 minutes of waiting for it to load so the veran representative walked around the corner to ct to confirm that they did not include scout scans on disk as we had instructed.As it turned out, the tech had included scouts, and proceeded to quickly burn a new disk.When the veran representative brought the disk to room the anesthesiologist was giving the patient nitrous oxide to begin the anesthetic for the procedure.The veran representative quickly cancelled the plan that had still not uploaded and told the physician hei was hopeful this new disk would load in 10-15 minutes.The disk took 10 more minutes to load, then once clicking through the carina selection screen, the software crashed.It would not allow us to reopen planning, and the physician said he would like to cancel the procedure and ebus and complete them on (b)(6) 2020 instead.The patient stopped receiving nitrous oxide through the mask and the physician rescheduled him for (b)(6) 2020.Updated (b)(6) 2020: patient received navigational bronchoscopy with no issues, procedure lasted 12 minutes and physician took multiple samples with forceps, 19g, and triple needle brush.

• Brand Name: SPIN PLANNING SOFTWARE APPLICATION
• Common Device Name: SPIN PLANNING SOFTWARE APPLICATION
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC; 1908 innerbelt business center; saint louis, mo
• MDR Report Key: 10418046
• Report Number: 3007222345-2020-00009
• Device Sequence Number: 19750831
• Product Code: JAK
• UDI-Device Identifier: 00815686021085
• UDI-Public: 00815686021085
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SFT-0010
• Device Catalogue Number: SFT-0010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Weight: 118