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 Micturition Urgency (1871); Pain (1994); Urinary Frequency (2275); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Tissue Injury (4559); Urinary Incontinence (4572)

Event Date 04/05/2023

Event Type  Injury  

Event Description

It was reported that, following a convective radiofrequency water vapor thermal therapy procedure, the patient has experienced constant urinary spasms.He stated that he had pain upon bladder release as well as pain in his urinary tract.The patient speculated the urinary tract pain may be due to damage from the catheter placed post-procedure, which he believes was inserted too deeply.He also experienced pain in his prostate area when sitting.Additionally, since the procedure, he stated he is experiencing urinary frequency and urgency issues and incontinence.Medication was prescribed for the urgency and the patient stated he is taking painkillers.No further patient complications were reported.

• 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16800072
• MDR Text Key: 313866911
• Report Number: 2124215-2023-17258
• 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: 04/24/2023

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: 04/10/2023
• Initial Date FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other