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

Model Number D2201

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

Patient Problems Fatigue (1849); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Weakness (2145); Dizziness (2194)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

The procedure was performed by dr.(b)(6) at the (b)(6) medical center located in (b)(6).

Event Description

It was reported the patient underwent convective radiofrequency water vapor thermal therapy procedure of the prostate.The patient indicated that the procedure was done at the physician s office and it was extremely painful.Post procedure the patient experienced urinary retention on two occasions leading to catheter placement on august 9th and august 12th.The patient went to the emergency room (er) for a third time on august 14th as he felt dizzy, weak, fatigued, and the blood pressure dropped below 120.No diagnosis was made during the er visits.The patient indicated that the catheter replacement lead to testicular infection.Although the urination stream was currently fine, the patient felt an ache on the penis lining and anus after urination.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: alyson harris ; 150 baytech drive; san jose, CA 95134 ; 4089353452
• MDR Report Key: 10960412
• MDR Text Key: 219982611
• Report Number: 3001236349-2020-00027
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K191505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 12/07/2020

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: D2201
• Device Catalogue Number: D2201
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/07/2020
• 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): Other; Required Intervention