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); Insufficient Information (4580)

Event Date 01/10/2022

Event Type  Injury  

Event Description

It was reported that during a water vapor therapy procedure, a patient experienced intense pain during insertion of the delivery device and during delivery of treatment.The patient had been administered oral sedation.Five second into the procedure, the patient demanded the physician to stop the procedure.The patient hands shook for over an hour after the procedure was stopped.The procedure was cancelled, and the patient sent home.The patient returned later that day in retention.It was further noted that the delivery device was confirmed to be in good condition after unpacking and preparation.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

Event Description

It was reported that during a water vapor therapy procedure, a patient experienced intense pain during insertion of the delivery device and during delivery of treatment.The patient had been administered oral sedation.Five second into the procedure, the patient demanded the physician to stop the procedure.The patient hands shook for over an hour after the procedure was stopped.The procedure was cancelled and the patient was sent home.The patient returned later that day due to urinary retention caused by the inflammation from the procedure.It was further noted that the delivery device was confirmed to be in good condition after unpacking and preparation and that there was no delivery device performance issues during the procedure.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, or regarding any treatment for the patient urinary retention, despite good faith efforts.

Event Description

It was reported that during a water vapor therapy procedure, a patient experienced intense pain during insertion of the delivery device and during delivery of treatment.The patient had been administered oral sedation.Five second into the procedure, the patient demanded the physician to stop the procedure.The patient hands shook for over an hour after the procedure was stopped.The procedure was cancelled and the patient was sent home.The patient returned later that day due to urinary retention caused by the inflammation from the procedure.It was further noted that the delivery device was confirmed to be in good condition after unpacking and preparation and that there was no delivery device performance issues during the procedure.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, or regarding any treatment for the patient urinary retention, despite good faith efforts.

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.Boston scientific has been unable to obtain additional information regarding the hand shaking patient symptom, follow up treatments and patient current status to date, despite good faith efforts.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 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 pain, urinary retention and inflammation 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: 13596035
• MDR Text Key: 286935096
• Report Number: 2124215-2022-05442
• 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,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• 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: 03/09/2022
• 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