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 Low Blood Pressure/ Hypotension (1914); Muscle Weakness (1967); Nausea (1970); Pain (1994); Sepsis (2067); Dizziness (2194); Numbness (2415); Diaphoresis (2452)

Event Date 01/28/2022

Event Type  Injury  

Event Description

It was reported that a patient experienced pain during a water vapor therapy procedure, lidocaine was administrated and did not have the desired effect.Patient states after the procedure, he experienced nausea, light headedness, drenching sweat, numbness in the left hand and arm and a drop in blood pressure and loss of strength.The patients wife called emergency (911) and the patient was rushed to the hospital and kept overnight.Patient states that toxins were released into his bloodstream, and he experienced a brush with sepsis.

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 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.The reported device performance allegation cannot be confirmed.Labeling review a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Pain, nausea and hypotension 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 a patient experienced pain during a water vapor therapy procedure, lidocaine was administrated and did not have the desired effect.Patient states after the procedure, he experienced nausea, light headedness, drenching sweat, numbness in the left hand and arm and a drop in blood pressure and loss of strength.The patients wife called emergency (911) and the patient was rushed to the hospital and kept overnight.Patient states that toxins were released into his bloodstream, and he experienced a brush with sepsis.

• 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: 13606446
• MDR Text Key: 286261334
• Report Number: 2124215-2022-05725
• 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: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• 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: 03/11/2022
• 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; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male