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 Urinary Frequency (2275); Discomfort (2330); Dysuria (2684); Insufficient Information (4580)

Event Date 09/23/2021

Event Type  Injury  

Event Description

Boston scientific became aware of a patient that had undergone a water vapor therapy procedure on (b)(6) 2021, at his urologist office.The day of the procedure, the patient had not been informed of needing to pick up his oral sedation medication prior to the procedure, so the treatment was delayed while the patient acquired and consumed the recommended pain management prescriptions.The patient described the procedure as being very uncomfortable and believed to have had 6 treatments delivered, each lasting 9 seconds.Post procedure, the patient was provided with instructions and "about 4 dozen catheters" for self catheterization.Two days after the procedure, the patient was still having difficulty urinating so the physician recommended to continue using the catheter.Two and a half weeks post-procedure ((b)(6) 2021), the patient was still having difficulty urinating so he went to the er (emergency room), and the physician placed a different type of catheter.The physician informed the patient that it appeared as though he had "catheter irritation in the urethra from continued self-catheterization".Urine specimen test was conducted showing crystals in the urine; the patient was prescribed antibiotics and sent home.The patient now is on medication for overactive bladder and is getting up 4 to 5 times per night to urinate whereas before the water vapor therapy procedure, the patient was getting up 2 to 3 times per night.The patient reported that he "has not gotten any better, only worse".The patient also mentioned that he was boiling and "sterilizing" his own catheters for reuse, however, the patient did not mention when he started sterilizing catheters post-procedure.The patient is to follow-up with the treating physician on january 4th to determine his next steps.No further information was provided.

Manufacturer Narrative

Correction: e1: initial reporter facility name - removed (b)(6) as the event was reported directly by a patient.Additional information provided by the patient: facility name - (b)(6).Investigation summary: there was no device available for analysis and there was no report of a device performance allegation during treatment.Crystals in the urine can occur for various reasons including dehydration, urine ph changes and diet.Bladder stones are anticipated in nature and severity as per the ifu and can be a result of crystals in the urine for a prolonged period of time.Based on the available information, the reported patient symptoms of discomfort, dysuria, urinary frequency and bladder stones are known risk 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 delivery device instructions for use (ifu) was reviewed.The patient symptoms of discomfort, dysuria, urinary frequency and bladder stones 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.

Event Description

Boston scientific became aware of a patient that had undergone a water vapor therapy procedure on (b)(6) 2021, at his urologist office.The day of the procedure, the patient had not been informed of needing to pick up his oral sedation medication prior to the procedure, so the treatment was delayed while the patient acquired and consumed the recommended pain management prescriptions.The patient described the procedure as being very uncomfortable and believed to have had 6 treatments delivered, each lasting 9 seconds.Post procedure, the patient was provided with instructions and "about 4 dozen catheters" for self catheterization.Two days after the procedure, the patient was still having difficulty urinating so the physician recommended to continue using the catheter.Two and a half weeks post-procedure ((b)(6) 2021), the patient was still having difficulty urinating so he went to the er (emergency room), and the physician placed a different type of catheter.The physician informed the patient that it appeared as though he had "catheter irritation in the urethra from continued self-catheterization".Urine specimen test was conducted showing crystals in the urine; the patient was prescribed antibiotics and sent home.The patient now is on medication for overactive bladder and is getting up 4 to 5 times per night to urinate whereas before the water vapor therapy procedure, the patient was getting up 2 to 3 times per night.The patient reported that he "has not gotten any better, only worse".The patient also mentioned that he was boiling and "sterilizing" his own catheters for reuse, however, the patient did not mention when he started sterilizing catheters post-procedure.The patient is to follow-up with the treating physician on (b)(6) to determine his next steps.No further information was provided.

• 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: 13022243
• MDR Text Key: 282381139
• Report Number: 2124215-2021-38053
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• 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: 12/23/2021
• 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