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	12/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Interoperative urethral perforation in a proact patient.
Additional Manufacturer Narrative
The first proact balloon was implanted without incident.During the dilation for the second proact balloon on the contalateral side of the urethra, the implanting physician performed much of the dilation without fluoroscopic guidance.During this dilation, the patient's urethra was perforated with the uromedica sharp-tipped trocar.The proact ifu instructs the user to "use fluoroscopy frequently to observe position and avoid bladder or urethral perforation".Although there was no immediate obvious sign of perforation (blood and/or urine in the u-channel sheath), the perforation was identified during post-implant cystoscopy.Patient sent home with foley catheter.There are plans to attempt implantation again in 6-8 weeks when the perforation has healed.Uromedica (b)(4).
Additional Manufacturer Narrative
The first proact balloon was implanted without incident.During the dilation for the second proact balloon on the contalateral side of the urethra, the implanting physician performed much of the dilation without fluoroscopic guidance.During this dilation, the patient's urethra was perforated with the uromedica sharp-tipped trocar.The proact ifu instructs the user to "use fluoroscopy frequently to observe position and avoid bladder or urethral perforation".Although there was no immediate obvious sign of perforation (blood and/or urine in the u-channel sheath), the perforation was identified during post-implant cystoscopy.Patient sent home with foley catheter.There are plans to attempt implantation again in 6-8 weeks when the perforation has healed.Uromedica (b)(4).
Event or Problem Description
Interoperative urethral perforation in a proact patient.

• Brand Name: IMPLANTATION INSTRUMENT SET - SHARP-TIP TROCAR
• Common Device Name: TROCAR
• Manufacturer (Section D): UROMEDICA, INC; 1840 berkshire lane north; plymouth MN 55441
• Manufacturer (Section G): UROMEDICA, INC; 1840 berkshire lane north; plymouth MN 55441
• Manufacturer Contact: robert mclain ; 1840 berkshire lane north; plymouth, MN 55441 ; 7636949880
• MDR Report Key: 13054388
• Report Number: 3003477176-2021-00018
• Device Sequence Number: 16546430
• Product Code: EZY
• UDI-Device Identifier: 00180668000106
• UDI-Public: 00180668000106
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 12/21/2021

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
• Device Lot Number: UM00831
• 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: 12/16/2021
• Initial Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2021
• 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: Required Intervention
• Patient Sex: Male