MAUDE Adverse Event Report: UROMEDICA, INC IMPLANTATION INSTRUMENT SET - SHARP-TIP TROCAR

Model Number	750041
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	07/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Urethral perforation at the bladder neck in a proact patient during implant.Patient successfully implanted.Proact balloons placed at the apex of the prostate rather than the bladder neck, the original intended location.Perforation treated via catheterization.

• Brand Name: IMPLANTATION INSTRUMENT SET - SHARP-TIP TROCAR
• Common Device Name: TROCAR
• Manufacturer (Section D): UROMEDICA, INC; 1840 berkshire lane north; plymouth MN 55441
• MDR Report Key: 12263341
• Report Number: 3003477176-2021-00009
• Device Sequence Number: 3900974
• Product Code: EZY
• UDI-Device Identifier: 00180668000106
• UDI-Public: 00180668000106
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 08/02/2021

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: 750041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 08/02/2021
• 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