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 Problem Sexual Dysfunction (4510)

Event Date 12/06/2021

Event Type  Injury  

Event Description

It was reported that the patient was enrolled in the vapeur rct study on (b)(6) 2021.At baseline there no abnormal findings, uti status was negative, and hematuria was not present.The prostate volume was calculated to be 39.5138 cm3.The patient had the following medical history: gastric ulcer in 1980 that resolved, tuberculosis in 1990 that resolved, viral meningitis in 2000 that resolved, and rheumatoid spondylitis in 2008 that is ongoing.Ongoing medication at baseline included methotrexate.Folic acid, vilanterol and umeclid.The patient underwent a water vapor therapy procedure under anesthesia.He received 1 treatment in the right lobe, 1 treatment in the left lobe, and 2 treatments in the median lobe.During the procedure there were no adverse events or device observations noted, and the procedure was completed without complications.He was not prescribed prophylactic antibiotics.He was discharged with an indwelling catheter which was removed by a nurse at the patient's home seven days post procedure.Post procedure, the patient experienced a loss of sexual function.No action was taken to treat the event.At the time of reporting, the event was not resolved, and no additional information was available.The physician believes there is a causal relationship between the rezum device/procedure and the patients loss of sexual function.

Event Description

It was reported that the patient was enrolled in the vapeur rct study on (b)(6) 2021.At baseline there no abnormal findings, uti status was negative, and hematuria was not present.The prostate volume was calculated to be 39.5138 cm3.The patient had the following medical history: gastric ulcer in 1980 that resolved, tuberculosis in 1990 that resolved, viral meningitis in 2000 that resolved, and rheumatoid spondylitis in 2008 that is ongoing.Ongoing medication at baseline included methotrexate.Folic acid, vilanterol and umeclid.The patient underwent water vapor therapy procedure under anesthesia.He received 1 treatment in the right lobe, 1 treatment in the left lobe, and 2 treatments in the median lobe.During the procedure there were no adverse events or device observations noted, and the procedure was completed without complications.He was not prescribed prophylactic antibiotics.He was discharged with an indwelling catheter which was removed by a nurse at the patient's home seven days post procedure.Post procedure, the patient experienced a loss of sexual function.No action was taken to treat the event.At the time of reporting, the event was not resolved and no additional information was available.The physician believes there is a causal relationship between the rezum device/procedure and the patient's loss of sexual function.

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 symptom is a known risk associated with water vapor therapy procedures and is noted as such in the device instructions for use.Device history record (dhr) review: although a batch number was provided, a dhr review cannot be completed based on this batch number as this batch number is tied only to the labeling.The batch number needed to complete the dhr review can only be identified by examining the device.The device was not returned for analysis resulting in an inability to identify the correct lot number.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 sexual dysfunction 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: 13840908
• MDR Text Key: 287549997
• Report Number: 2124215-2022-07922
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2023
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 0027544935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 77 KG