MAUDE Adverse Event Report: UROMEDICA, INC. PROACT BLUNT TROCAR, PACKAGED (USA)

Model Number	750042
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Fluid Discharge (2686)
Date of Event	06/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dr.(b)(6) was presiding the case with a resident assisting.The patient's bladder was perforated with the blunt trocar and fluid ran out of the paired u-sheath when the blunt trocar was removed.The physician placed the balloon, which was delivered to the bladder.The physician then implanted a balloon on the contralateral side, after which, he deflated and removed the balloon that had been placed on the side that had been perforated.The patient was then catheterized with plans for implanting a second balloon on the perforated side after the perforation has adequately healed.(b)(4).
Event or Problem Description
Bladder perforation during a proact implantation procedure.Patient was treated with a catheter.

• Brand Name: PROACT BLUNT TROCAR, PACKAGED (USA)
• Common Device Name: TROCAR
• Manufacturer (Section D): UROMEDICA, INC.; 1840 berkshire lane north; plymouth MN 55441
• MDR Report Key: 11995718
• Report Number: 3003477176-2021-00006
• Device Sequence Number: 922280
• Product Code: EZY
• UDI-Device Identifier: 00180668000137
• UDI-Public: 0100180668000137
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 06/14/2021

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 06/14/2021
• 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