MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Urinary Retention (2119); Unspecified Kidney or Urinary Problem (4503); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 02/01/2024

Event Type  Injury  

Manufacturer Narrative

There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.B3 date of event: approximated.

Event Description

It was reported that the patient underwent a rezum procedure, with the catheter removed two days later.However, another two days later, the patient required catheter placement again, which remained in situ for five days until its removal.The following day, the patient was able to void successfully.However, the day later, the patient experienced urinary retention and sought medical attention at the emergency room.Subsequently, the patient was catheterized for two days and was then admitted to the hospital due to continued urinary difficulties attributed to bladder spasms.While hospitalized, the patient received intravenous antibiotics, including levaquin and septra, despite testing negative for urinary tract infection.Then, the patient was discharged and had a ct scan which indicated the patient had a collapsed bladder.The patient is currently having urine retention and self-catheterizing 3-5 times a day on flomax.The patient started seeing another dr and is having a urodynamic test soon.No further information was provided.

• Brand Name: REZUM
• Type of Device: UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18976111
• MDR Text Key: 338547914
• Report Number: 2124215-2024-17468
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2024

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Age: 62 YR
• Patient Sex: Male