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 Problem Hematuria (2558)

Event Date 09/29/2021

Event Type  Injury  

Manufacturer Narrative

K.Eredics, c wehrberger, a.Henning, s.Sevcenco, m.Marszalek, m.Rauchenwald, c.Falkensammer, u.Stoces, s.Maderbacher, m.Horetzky, t.Kunit and l.Lusuardi."rezum water vapor therapy in multimorbid patients with urinary retention and catheter dependency." springer nature, published online 29 september 2021.

Event Description

It was reported via an article published in springer nature that a retrospective review was conducted in order to determine the safety and efficacy of water vapor therapy procedures in patients meeting the following criteria: anesthesia-ineligible, recurrent urinary retention, indwelling catheter, at least one unsuccessful trial without catheter (twoc), and under alpha-blocker therapy.The medical record of 136 men who underwent water vapor therapy procedure at three different urological departments between october 2017 and february 2021 were reviewed.The mean age of the patients was 80.3 years, the mean prostate volume was 54 ml, and the mean duration of catheter dependence was 4.8 months.Patient's with a prostate volume less than 20 ml were excluded.27 of the patients had diabetes and 28 of the patients had neurological disorders.All procedures were performed under local anesthesia and in an ambulatory setting.All procedures were completed successfully without serious perioperative complications.Following the procedures and prior to discharge, all patients received a single dose of 3g oral fosfomycin or an alternative antibiotic.Following the procedure, the patients had a catheter left in place for 1 to 4 weeks in order to allow for sufficient reduction of swelling and a prolonged resolution of obstruction.Further follow-up visits were scheduled after 3- and 12-months post-op.Following the procedure, 6 patients (4.4%) experienced gross hematuria which was treated with insertion of an irrigation catheter for 24-72 hours.5 patients (3.9%) experienced a urinary tract infection following the procedure.4 of these infections were managed with oral antibiotics and one patient required hospitalization for parenteral antibiotic therapy.4 patients required repeated surgical intervention; 3 patients received water vapor therapy again and one patient underwent transurethral resection of the prostate (turp).In the end, 90% of the patients were catheter free 12 months following the procedure.15 patients died during follow-up with a mean survival of 7.7 months after the procedure.The cause of the deaths was not included in the article.It was not possible to ascertain specific device per patient or facility data from the article.No further information is available.This report is for the gross hematuria reported.

Manufacturer Narrative

There was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptoms are known risk associated with implants of these device as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.Correction information provided in h6: impact codes.K.Eredics, c wehrberger, a.Henning, s.Sevcenco, m.Marszalek, m.Rauchenwald, c.Falkensammer, u.Stoces, s.Maderbacher, m.Horetzky, t.Kunit and l.Lusuardi."rezum water vapor therapy in multimorbid patients with urinary retention and catheter dependency." springer nature, published online 29 september 2021.

Event Description

It was reported via an article published in springer nature that a retrospective review was conducted in order to determine the safety and efficacy of water vapor therapy procedures in patients meeting the following criteria: anesthesia-ineligible, recurrent urinary retention, indwelling catheter, at least one unsuccessful trial without catheter (twoc), and under alpha-blocker therapy.The medical record of 136 men who underwent water vapor therapy procedure at three different urological departments between october 2017 and february 2021 were reviewed.The mean age of the patients was 80.3 years, the mean prostate volume was 54 ml, and the mean duration of catheter dependence was 4.8 months.Patient's with a prostate volume less than 20 ml were excluded.27 of the patients had diabetes and 28 of the patients had neurological disorders.All procedures were performed under local anesthesia and in an ambulatory setting.All procedures were completed successfully without serious perioperative complications.Following the procedures and prior to discharge, all patients received a single dose of 3g oral fosfomycin or an alternative antibiotic.Following the procedure, the patients had a catheter left in place for 1 to 4 weeks in order to allow for sufficient reduction of swelling and a prolonged resolution of obstruction.Further follow-up visits were scheduled after 3- and 12-months post-op.Following the procedure, 6 patients (4.4%) experienced gross hematuria which was treated with insertion of an irrigation catheter for 24-72 hours.5 patients (3.9%) experienced a urinary tract infection following the procedure.4 of these infections were managed with oral antibiotics and one patient required hospitalization for parenteral antibiotic therapy.4 patients required repeated surgical intervention; 3 patients received water vapor therapy again and one patient underwent transurethral resection of the prostate (turp).In the end, 90% of the patients were catheter free 12 months following the procedure.15 patients died during follow-up with a mean survival of 7.7 months after the procedure.The cause of the deaths was not included in the article.It was not possible to ascertain specific device per patient or facility data from the article.No further information is available.The physician subsequently confirmed that the patient's deaths were no related to the procedure or device.There were no difficulties encountered during the procedure.This report is for the gross hematuria 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 ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15139965
• MDR Text Key: 296987823
• Report Number: 2124215-2022-27981
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2022
• 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