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 Inflammation (1932); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Hematuria (2558); Dysuria (2684); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/26/2021

Event Type  Injury  

Manufacturer Narrative

The exact event date is unknown.The date reflected is based on an approximate 6 weeks from the patient's report to bsc and applying the internal guidance.(b)(6).

Event Description

Boston scientific became aware of a patient experience with rezum on (b)(6) 2021.The patient reported that he underwent a water vapor therapy procedure approximately 6 weeks ago, and to date, the patient is unable to urinate most time of the day without extreme pain.The patient ended up with a catheter for almost two weeks and made two trips to the local emergency room; the first time was due to being unable to urinate at all and the second time was due to extreme pain when urinating.Even after 6 weeks post water vapor therapy procedure, the patient is still experiencing some bleeding with urination.For the first time since the water vapor therapy procedure, the patient had intercourse and reported that his orgasm, while painful, was also dry.The patient also recently developed epididymitis and was prescribed antibiotic that resulted in hives.The patient acknowledges that his condition may be unusual, but he believes boston scientific (bsc) literature does not advise adequately regarding the risks and complications that can result from water vapor therapy procedure.The patient does not know when he can expect to begin to feel better but he does know that the past 6 weeks have been a very negative life changing experience.

Manufacturer Narrative

Section e: (b)(6).

Event Description

Boston scientific became aware of a patient experience with rezum on (b)(6) 2021.The patient reported that he underwent a water vapor therapy procedure approximately 6 weeks ago, and to date, the patient is unable to urinate most time of the day without extreme pain.The patient ended up with a catheter for almost two weeks and made two trips to the local emergency room; the first time was due to being unable to urinate at all and the second time was due to extreme pain when urinating.Even after six weeks post water vapor therapy procedure, the patient is still experiencing some bleeding with urination.For the first time since the water vapor therapy procedure, the patient had intercourse and reported that his orgasm, while painful, was also dry.The patient also recently developed epididymitis and was prescribed antibiotic that resulted in hives.The patient acknowledges that his condition may be unusual, but he believes boston scientific (bsc) literature does not advise adequately regarding the risks and complications that can result from water vapor therapy procedure.The patient does not know when he can expect to begin to feel better but he does know that the past six weeks have been a very negative life changing experience.Further information was received indicating that the procedure was completed successfully and there was no issue with the device.The device was disposed.The patient was seen for acute urinary retention (aur) three days post water vapor therapy procedure.The catheter needed to be drained and an infection followed.The patient was treated with bactrim and later with doxycycline due to a rash from bactrim.The patient also developed epididymitis that has since resolved.The patient is still being monitored until the urinary tract infection (uti) clears.

Event Description

Boston scientific became aware of a patient experience with rezum on (b)(6) 2021.The patient reported that he underwent a water vapor therapy procedure approximately 6 weeks ago, and to date, the patient is unable to urinate most time of the day without extreme pain.The patient ended up with a catheter for almost two weeks and made two trips to the local emergency room; the first time was due to being unable to urinate at all and the second time was due to extreme pain when urinating.Even after 6 weeks post water vapor therapy procedure, the patient is still experiencing some bleeding with urination.For the first time since the water vapor therapy procedure, the patient had intercourse and reported that his orgasm, while painful, was also dry.The patient also recently developed epididymitis and was prescribed antibiotic that resulted in hives.The patient acknowledges that his condition may be unusual, but he believes boston scientific (bsc) literature does not advise adequately regarding the risks and complications that can result from water vapor therapy procedure.The patient does not know when he can expect to begin to feel better but he does know that the past 6 weeks have been a very negative life changing experience.Further information was received indicating that the procedure was completed successfully and there was no issue with the device.The device was disposed.Patient was seen for acute urinary retention (aur) 3 days post water vapor therapy procedure.The catheter needed to be drained and an infection followed.The patient was treated with bactrim and later with doxycycline due to a rash from bactrim.Patient also developed epididymitis that has since resolved.The patient is still being monitored until the urinary tract infection (uti) clears.

Manufacturer Narrative

Section e: dr.(b)(6).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 of urinary retention, dysuria, hematuria, inflammation, retrograde ejaculation, pain and urinary tract infection 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 were 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 delivery device instructions for use (ifu) was reviewed.The patient symptoms of urinary retention, dysuria, hematuria, inflammation, retrograde ejaculation, pain and urinary tract infection were found to be listed in the ifu.Investigation conclusion: based on the information available, a conclusion code of known inherit risk of device was assigned to this investigation.

• 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: 13028623
• MDR Text Key: 282483462
• Report Number: 2124215-2021-38247
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• 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?: No
• Date Manufacturer Received: 12/27/2021
• 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