MAUDE Adverse Event Report: UROMEDICA, INC. PROACT IMPLANTATION INSTRUMENT SET; SURGICAL INSTRUMENTS

Model Number 750041-01

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problem Perforation (2001)

Event Date 10/21/2019

Event Type  Injury  

Manufacturer Narrative

The patient injury occurred during a proact implant procedure.Two physicians were in training with dr.(b)(6) proctoring on the case.Dr.(b)(6) performed implant on the patient's left side.Dr.(b)(6) then performed implant on the patient's right side with no complications.It was then noted that contrast could be seen on the instrument.A perforation was confirmed on the initial implant using fluoroscopy, and that the balloon implanted on the patient's left side had been placed in the urethra, which was confirmed with cystoscope imagry.Dr.(b)(6) then removed the left implanted balloon and catheterized the patient.The right implanted balloon was left in place.The patient was discharged with an antibiotic regimen.The physician intends to finish the case with the left implant at a later time.

Event Description

A urethral perforation occurred during an implant procedure using uromedica devices.

• Brand Name: PROACT IMPLANTATION INSTRUMENT SET
• Type of Device: SURGICAL INSTRUMENTS
• 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: lisa van ryn ; 1840 berkshire lane north; plymouth, MN 55441 ; 7636949880
• MDR Report Key: 9304951
• MDR Text Key: 167145880
• Report Number: 3003477176-2019-00065
• Device Sequence Number: 1
• Product Code: KOA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2019

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
• Device Operator: Health Professional
• Device Model Number: 750041-01
• Device Lot Number: UM00677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 11/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention