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

Model Number 750041

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Internal Organ Perforation (1987)

Event Date 09/11/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 325426697
• Report Number: 3003477176-2023-00021
• Device Sequence Number: 1
• Product Code: EZY
• UDI-Device Identifier: 00180668000106
• UDI-Public: 00180668000106
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 750041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male