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	09/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Performing routine proact on naive patient.Both balloons were placed, left balloon more medial than original deployment to the urethra.Fluoroscopy indicated that the bladder with contrast was deflating.A small urethral perforation was identified at the 3 o clock position.The left side was aborted and the device was not placed.The right side was left in place.Treatment - a catheter was placed and will be left for 5 days.Conclusion - this would have occurred with the sharp trocar or open u-channel.
Event or Problem Description
Both balloons were placed but dr.Art opted to place the left balloon more medial than original deployment to the urethra.Upon subsequent fluoroscopy, it was noticed that the bladder with contrast was deflating.A small urethral perforation was identified at the 3 o clock position.This would have occurred with the sharp trocar or open u-channel.The left side was aborted and the device was not placed.The right side was left in place.Revision left side scheduled for (b)(6) 2023.

• Brand Name: IMPLANTATION INSTRUMENT SET - SHARP TIP TROCAR
• Common Device Name: TROCAR
• Manufacturer (Section D): UROMEDICA INC.; 1840 berkshire lane n; plymouth MN 55441
• Manufacturer (Section G): UROMEDICA INC.; 1840 berkshire lane n; plymouth MN 55441
• Manufacturer Contact: jean russell ; 1840 berkshire lane n; plymouth, MN 55441 ; 7636949880
• MDR Report Key: 17916219
• Report Number: 3003477176-2023-00021
• Device Sequence Number: 6804243
• Product Code: EZY
• UDI-Device Identifier: 00180668000106
• UDI-Public: 00180668000106
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2023

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 Model Number: 750041
• 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: 09/11/2023
• Initial Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male