MAUDE Adverse Event Report: PROFOUND MEDICAL INC TULSA-PRO SYSTEM; High intensity ultrasound system for prostate tissue ablation

Model Number	109171
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mdr-fda-3500a form was submitted to fda within the required 30 days in paper format through mail.We were following a conflicting fda guidance that specify that medical devices fda-3500a form should be send by mail to fda.The fda rejected the paper form and recomended that we should re-submit the fda 3500a form electronically through esubmitter.Since this is our first electronic report, it was delayed due to signup process.
Event or Problem Description
On (b)(6) 2023, patient underwent a prostate ablation procedure with the tulsa-pro transurethral ultrasound ablation system.The procedure involves insertion of an endorectat cooling device (ecd) for passive cooling of the rectum during the ablation procedure.The treating urologist reported that during device insertion, initial imaging revealed that the ecd was not properly inserted and an adjustment was required to insert the device further inwards.The urologist reported that she felt resistance during the insertion but eventually was capable to push the device further inside the body.Subsequent mr images, showed the proper placement of the ecd and the team proceeded with the ultrasound treatment of the prostate with no unusual issues related to rectal cooling.The following day ((b)(6) 2023), patient reported pain in his stomach.Follow-up ct images revealed rectal perforation beyond the treatment area where the ecd tip ends.The radiologist suspects that this perforation has happened due to the mechanical damage done by the excessive insertion of the ecd.Radiologist mentioned that the patient had previous prostate radiation therapy and therefore his rectal tissue could be vulnerable and unstable.The patient received additional surgical intervention of protective stoma and vac (vacuum-assisted closure) on the hole in the rectal wall, which resulted in prolonged hospitalization.

• Brand Name: TULSA-PRO SYSTEM
• Common Device Name: High intensity ultrasound system for prostate tissue ablation
• Manufacturer (Section D): PROFOUND MEDICAL INC; 2400 skymark avenue 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: nicole baker ; 2400 skymark avenue unit#6; mississauga, ontario L4W 5-K5 ; CA L4W 5K5
• MDR Report Key: 17101694
• Report Number: 3012604011-2023-00001
• Device Sequence Number: 13948972
• Product Code: PLP
• UDI-Device Identifier: 07540281001370
• UDI-Public: (01)07540281001370(10)JD10140(11)220502(17)250502
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K211858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2023

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 Expiration Date: 05/02/2025
• Device Model Number: 109171
• Device Catalogue Number: 109171
• Device Lot Number: JD10140
• 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: 03/02/2023
• Initial Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2022
• 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: Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White