MAUDE Adverse Event Report: MEDTRONIC ENGINEERING AND INNOVATION CENTER (MEIC) TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES)

Patient Problems Fever (1858); Pain (1994); Uterine Perforation (2121); Bowel Perforation (2668)

Event Date 09/08/2023

Event Type  Injury  

Event Description

Subject: request for investigation into medical device safety - truclear by medtronic to the fda: i am writing to bring to your attention a series of concerning events and issues surrounding my recent medical care at (b)(6) hospital in (b)(6), specifically related to the use of the medical device truclear by medtronic.After consulting with legal and medical experts, it has become apparent that serious complications, including a potentially life-threatening bowel perforation, may have resulted from the use of this product during my treatment in (b)(6) 2023.Despite this, both (b)(6) and medtronic are refusing to accept responsibility for this complication, leaving me deeply concerned about the safety of this device.I was approximately 6 weeks pregnant when, on (b)(6) 2023, i noticed my morning sickness abruptly disappeared.Following a series of appointments, including ultrasounds confirming the presence of a heartbeat, i underwent a hysteroscopy under iv sedation at (b)(6) on (b)(6) 2023.I was discharged the same day but experienced severe pain and fever the following day.Diagnostic testing revealed a uterine perforation, with a suspected bowel perforation, necessitating emergency surgery for repair and a five-day hospital stay, as well as multiple subsequent er visits.Upon reviewing the events, it has come to my attention that the use of truclear by medtronic during the hysteroscopy may have contributed to the complications i experienced.The lack of acknowledgment or investigation by either (b)(6) or medtronic is deeply concerning, especially given the life-threatening nature of the complications.Therefore, i am requesting a full investigation by the fda into the safety of the truclear device manufactured by medtronic.It is imperative that the safety and efficacy of this product are thoroughly examined to prevent similar incidents from occurring in the future and to ensure the well-being of patients undergoing procedures utilizing this device.Sincerely, (b)(6).

• Brand Name: TRUCLEAR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MEDTRONIC ENGINEERING AND INNOVATION CENTER (MEIC)
• MDR Report Key: 18922129
• MDR Text Key: 338110764
• Report Number: MW5152918
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/13/2024

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?: Yes
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Sex: Female