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 Inflammation (1932); Hematuria (2558); Erectile Dysfunction (4511)

Event Date 05/12/2021

Event Type  Injury  

Event Description

It was reported that the patient presented with an international prostate symptom score (ipps) of 28, an international index of erectile function (iief) score of 4 and a prostate volume of 53 cm3.The patient is a chinese male with medical history of gastrointestinal and neurological disorders.The patient was enrolled into the clinical study.During the water vapor therapy procedure of the prostate, there were a total of three treatments delivered to the right lobe, four treatments to the left lobe and one treatment to the middle lobe.Three days following the index procedure, the patient was reported to be experiencing hematuria.The patient was discharged from the medical facility on tamsulosin hydrochloride sustained-release capsule (dose unknown).At 34 days post the index procedure, the patient experienced erectile dysfunction and an urinary volume assessment test completed at 36 days post the index procedure, found the urinary volume at 142 ml with peak flow rate of 11 ml/sec.152 days post the index procedure, the patient was diagnosed with prostatitis.The symptom of prostatitis was not considered to be resolved, and per the electronic data center (edc), there was no action taken to treat it.The investigator assessed the patient symptom of prostatitis as possible related to the procedure and device.

Manufacturer Narrative

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 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 hematuria and erectile dysfunction 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 that the patient presented with an international prostate symptom score (ipps) of 28, an international index of erectile function (iief) score of 4 and a prostate volume of 53 cm3.The patient is a chinese male with medical history of gastrointestinal and neurological disorders.The patient was enrolled into the clinical study.During the water vapor therapy procedure of the prostate, there were a total of three treatments delivered to the right lobe, four treatments to the left lobe and one treatment to the middle lobe.Three days following the index procedure, the patient was reported to be experiencing hematuria.The patient was discharged from the medical facility on tamsulosin hydrochloride sustained-release capsule (dose unknown).At 34 days post the index procedure, the patient experienced erectile dysfunction and an urinary volume assessment test completed at 36 days post the index procedure, found the urinary volume at 142 ml with peak flow rate of 11 ml/sec.152 days post the index procedure, the patient was diagnosed with prostatitis.The symptom of prostatitis was not considered to be resolved, and per the electronic data center (edc), there was no action taken to treat it.The investigator assessed the patient symptom of prostatitis as possible related to the procedure and device.

• 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
• MDR Report Key: 12358242
• MDR Text Key: 267815978
• Report Number: 2124215-2021-25378
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00191506006785
• UDI-Public: 00191506006785
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2022
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 0026343797
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR