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); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Discomfort (2330); Erectile Dysfunction (4511)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact event date of starting symptom from index procedure is unknown.Investigation summary: based on the information available, 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 risks associated with water vapor therapy procedures and are noted as such in the device instructions for use.Device history record (dhr): a dhr and ship history review cannot be performed as the lot number was not available.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: the device instructions for use (ifu) was reviewed.The patient symptoms of discomfort, pain, urinary retention, infection, impotence and urinary urgency were found to be listed in the ifu.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

It was reported a patient underwent a water vapor therapy procedure of the prostate.During the procedure the patient reported to have experienced discomfort even with the recommended local sedation.After the water vapor therapy treatment, a catheter was placed.The urine bag filled to a full liter immediately after the patient stood up.The medical staff emptied the bag and there was no concern about this response to the treatment until the following few weeks.A week after the treatment, the physician removed the catheter and did a void test.The patient could not void and described the void attempt as very painful.The physician put the catheter back in and sent the patient home for another week.After a week, the catheter was then removed, and the patient was sent home.The patient experienced difficulty voiding and urinating without pain.The patient went to the emergency room (er) and another catheter was inserted.Two weeks later, the catheter was removed and the patient was sent home again.The same symptoms of difficulty voiding and urinating with severe pain occurred again.The patient went to the er for a second time where they provided him with another catheter which the patient had for 6 weeks.The patient is about 3 months post-treatment and still has a catheter.In addition, the patient has an infection which is suspected to be from the catheter, and is still unable to urinate without pain.The patient gets up several times a night with the urge to urinate, and is experiencing erectile dysfunction.The patient is now on cialis daily (dose unknown) and stated that he never had a problem with erections prior to receiving the treatment.The patient has seen his doctor several times about current condition and urinary concerns, but he has not yet discussed solutions or plans to address his sexual function concerns.

Manufacturer Narrative

B3 date of event: the exact event date of starting symptom from index procedure is unknown investigation summary: based on the information available, 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 risks associated with water vapor therapy procedures and are noted as such in the device instructions for use.Device history record (dhr): a dhr and ship history review cannot be performed as the lot number was not available.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: the device instructions for use (ifu) was reviewed.The patient symptoms of discomfort, pain, urinary retention, infection, impotence and urinary urgency were found to be listed in the ifu.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

It was reported a patient underwent a water vapor therapy procedure of the prostate.During the procedure the patient reported to have experienced discomfort even with the recommended local sedation.After the water vapor therapy treatment, a catheter was placed.The urine bag filled to a full liter immediately after the patient stood up.The medical staff emptied the bag and there was no concern about this response to the treatment until the following few weeks.A week after the treatment, the physician removed the catheter and did a void test.The patient could not void and described the void attempt as very painful.The physician put the catheter back in and sent the patient home for another week.After a week, the catheter was then removed, and the patient was sent home.The patient experienced difficulty voiding and urinating without pain.The patient went to the emergency room (er) and another catheter was inserted.Two weeks later, the catheter was removed and the patient was sent home again.The same symptoms of difficulty voiding and urinating with severe pain occurred again.The patient went to the er for a second time where they provided him with another catheter which the patient had for 6 weeks.The patient is about 3 months post-treatment and still has a catheter.In addition, the patient has an infection which is suspected to be from the catheter, and is still unable to urinate without pain.The patient gets up several times a night with the urge to urinate, and is experiencing erectile dysfunction.The patient is now on cialis daily (dose unknown) and stated that he never had a problem with erections prior to receiving the treatment.The patient has seen his doctor several times about current condition and urinary concerns, but he has not yet discussed solutions or plans to address his sexual function concerns.It was further reported that the symptoms have persisted and the patient has experienced bladder infections from his bladder retaining urine.The patient recently received an antibiotic injection due to recurring infections.Another foley catheter will be placed.The prescribed cialis has not improved the impotence issues.

• 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 ; 4089353452
• MDR Report Key: 12447692
• MDR Text Key: 270573615
• Report Number: 2124215-2021-27289
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• 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: 11/02/2021
• 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; Other
• Patient Age: 55 YR
• Patient Sex: Male