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.

Manufacturer Narrative

The product was not returned so no physical analysis could be performed.A labeling review was performed, and patient symptoms urinary tract infection (uti), sepsis, urinary frequency and urinary incontinence are documented as a potential risks associated with the use of the device.There was no evidence that the device was used or handled improperly.Based on the information available, an evaluation conclusion code of known inherent risk of device was assigned to this investigation.

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 after the procedure.The patient was put under fourteen days of heavy antibiotics infusion.Six months after 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.The device worked as intended during 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
• 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
• PMA/PMN Number: K180237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

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: 05/28/2020
• Initial Date FDA Received: 06/24/2020
• Supplement Dates Manufacturer Received: 07/06/2020
• Supplement Dates FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other