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 Fever (1858); Micturition Urgency (1871); Incontinence (1928); Sepsis (2067); Urinary Tract Infection (2120); Chills (2191)

Event Date 12/02/2019

Event Type  Injury  

Event Description

It was reported by the patient that during convective radiofrequency water vapor thermal therapy, the injection of lidocaine though patients body released e-coli into bloodstream resulting in rigor, high fever and sepsis. The hospitalization came as a result three days post the procedure. The patient was put under fourteen days of heavy antibiotics infusion. Six months post the procedure, the patient still had benign prostatic hyperplasia (bph) and traces of e-coli in urine. The patient had two to three trips to urinate at night after falling asleep and the urine flow was very weak. The patient had bladder retention, getting up to urinate two or three times a night, erratic pressure flow, incontinence (urine leakage during the day). It was also reported by the patient that he had a terrible experience and to date poor results. The symptoms were same as before the procedure.

• 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 CORPORATATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 150 baytech drive; san jose, CA 95134 ; 4089353452
• MDR Report Key: 10192317
• MDR Text Key: 197020818
• Report Number: 2937094-2020-00527
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: D2201
• Device Catalogue Number: D2201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/06/2020
• 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 Treatment Data

Date Received: 06/24/2020 Patient Sequence Number: 1