MAUDE Adverse Event Report: UROMEDICA, INC. BLUNT TROCAR

Model Number	750042
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Fluid Discharge (2686)
Date of Event	08/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The perforation occurred during dilation with the blunt trocar on the patient's right side.The trocar punctured the pelvic floor and the patient's bladder.The perforation was identified by urine from the u-channel sheath and via flexible cystoscopy, which identified the exact location of the perforation.Prior to the first adjustment, the physician plans to confirm with cystoscopy that the proact device has not eroded or migrated into the bladder.(b)(4).
Event or Problem Description
Right-side bladder perforation during a proact implantation procedure.Patient successfully implanted.Right-side proact balloon was placed lateral to the perforation and distal to the bladder neck.Left-side implant was placed normally.Perforation was treated with a foley catheter.

• Brand Name: BLUNT TROCAR
• Common Device Name: TROCAR
• Manufacturer (Section D): UROMEDICA, INC.; 1840 berkshire lane north; plymouth MN 55441
• MDR Report Key: 12367475
• Report Number: 3003477176-2021-00010
• Device Sequence Number: 4536606
• Product Code: EZY
• UDI-Device Identifier: 00180668000137
• UDI-Public: 0100180668000137
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P130018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

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: 750042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 08/25/2021
• 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: Required Intervention