MAUDE Adverse Event Report: PROFOUND MEDICAL INC. TULSA-PRO® SYSTEM

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Pelvic Pain (4865)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Adverse event reported: "prolonged increased pain post-tulsa" patient has been suffering with severe bladder neck and rectal spasms since shortly after catheter removal post tulsa procedure.Tulsa procedure: on (b)(6) 2023, catheter removed: on (b)(6) 2023, bladder neck spasms: unknown (b)(6) 2023, rectal spasms: on (b)(6) 2023.Patient received multiple interventions, including bladder neck resection (b)(6) 2024.
Additional Manufacturer Narrative
Disposable components of the device were discarded following the treatment because no malfunction was identified during the procedure.System logs were retrieved to review intraprocedural imaging.Thermometry maps and mri images acquired throughout the procedure, and contrast-enhanced mri acquired immediately after the procedure revealed no evidence of overheating and confirmed a conservative ablation plan.There was no heating outside the prostate capsule.The post-treatment mri also shows no evidence of bladder or rectal injury.There was no significant motion observed during the treatment.
Event or Problem Description
This follow-up report is in reference to the initial form 3500a submitted may 31 2024 for the adverse event reported: "prolonged increased pain post-tulsa".Regarding patient management, since the initial report, the patient has undergone placement of a suprapubic catheter.The pain has resolved.The suprapubic catheter, however, is intended as a temporary measure and pain specialists are currently consulting on the case to assess whether definitive pain relief can be achieved without the need for catheterization by use of nerve block therapies.Gastronenterology consultation was also requested.
Additional Manufacturer Narrative
There has been no new evidence concerning root cause with regards to the device.Investigation is ongoing as described above.

• Brand Name: TULSA-PRO® SYSTEM
• Common Device Name: TULSA
• Manufacturer (Section D): PROFOUND MEDICAL INC.; 2400 skymark avenue unit 6; unit 6; mississauga, ontario L4W 5 K5; CA L4W 5K5
• Manufacturer (Section G): PROFOUND MEDICAL INC.; 2400 skymark avenue unit#6; mississauga, ontario L4W 5 K5; CA L4W 5K5
• Manufacturer Contact: norm morikawa ; 2400 skymark avenue unit#6; mississauga, ontario L4W 5-K5 ; CA L4W 5K5
• MDR Report Key: 19439595
• Report Number: 3012604011-2024-00001
• Device Sequence Number: 8393944
• Product Code: PLP
• UDI-Device Identifier: 07540281000014
• UDI-Public: 07540281000014
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K230692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 05/31/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White