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 Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Unspecified Reproductive System or Breast Problem (4513); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

The exact event date is unknown.

Event Description

It was reported that after receiving convective radiofrequency water vapor thermal therapy, the patient reported that it did not relieve or cure his benign prostatic hyperplasia (bph) and his condition worsened after the procedure.Specifically, when he senses an urgency to urinate, it is sudden and feels as if he has to urinate within a minute.The patient also has experienced retrograde ejaculation and loss of urine pressure, and feels that his bladder does not empty completely.The patient also expressed that he would not undergo the procedure again without general anesthesia, as both the local injections to numb his prostate and the procedure were intensely painful.The patient had no allegations against physician who performed the procedure.Boston scientific attempts to obtain further information about this case have been unsuccessful.No other adverse patient effects were reported.

Event Description

It was reported that after receiving convective radiofrequency water vapor thermal therapy, the patient reported that it did not relieve or cure his benign prostatic hyperplasia (bph) and his condition worsened after the procedure.Specifically, when he senses an urgency to urinate, it is sudden and feels as if he has to urinate within a minute.The patient also has experienced retrograde ejaculation and loss of urine pressure, and feels that his bladder does not empty completely.The patient also expressed that he would not undergo the procedure again without general anesthesia, as both the local injections to numb his prostate and the procedure were intensely painful.The patient had no allegations against physician who performed the procedure.Boston scientific attempts to obtain further information about this case have been unsuccessful.No other adverse patient effects were reported.

Manufacturer Narrative

B3: the exact event date is unknown.Initial reporter firs name, initial reporter last name and initial reporter email updated.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 risk associated with a water vapor therapy procedure 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 and facility account 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 retrograde ejaculation, urinary urgency, pain, and urinary retention 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.

Manufacturer Narrative

B3: the exact event date is unknown.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 water vapor therapies, 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.

Event Description

It was reported that after receiving convective radiofrequency water vapor thermal therapy, the patient reported that it did not relieve or cure his benign prostatic hyperplasia (bph) and his condition worsened after the procedure.Specifically, when he senses an urgency to urinate, it is sudden and feels as if he has to urinate within a minute.The patient also has experienced retrograde ejaculation and loss of urine pressure, and feels that his bladder does not empty completely.The patient also expressed that he would not undergo the procedure again without general anesthesia, as both the local injections to numb his prostate and the procedure were intensely painful.The patient indicated that he developed prostate cancer that lead to changes in the prostate gland, causing the water vapor therapy to not succeed.The patient had no allegations against physician who performed the procedure.Boston scientific attempts to obtain further information about this case have been unsuccessful.No other adverse patient effects were 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 ; 4089353452
• MDR Report Key: 11286995
• MDR Text Key: 230551333
• Report Number: 2937094-2021-00099
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2022
• 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): Other
• Patient Sex: Male