MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number D2201

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Pain (1994)

Event Date 09/09/2022

Event Type  Injury  

Event Description

It was reported that in preparation for a water vapor therapy procedure, the patient had been given a local anesthesia.After the delivery device was connected to the generator it initially was unable to complete the priming cycle and an error was received.The syringe was then refilled and connected to the generator.After that, the delivery device was able to successfully complete priming and perform the pretreatment cycle.While attempting to insert the delivery device into the patient, the patient experienced extreme pain.Once the delivery device was fully inserted, the doctor attempted to treat the patient.However; the physician only performed a partial treatment and then decided to abort the procedure because the patient was not tolerating the steam treatments well.There were no further patient complications.

Event Description

It was reported that in preparation for a water vapor therapy procedure, the patient had been given a local anesthesia.After the delivery device was connected to the generator it initially was unable to complete the priming cycle and an error was received.The syringe was then refilled and connected to the generator.After that, the delivery device was able to successfully complete priming and perform the pretreatment cycle.While attempting to insert the delivery device into the patient, the patient experienced extreme pain.Once the delivery device was fully inserted, the doctor attempted to treat the patient.However, the physician only performed a partial treatment and then decided to abort the procedure because the patient was not tolerating the steam treatments well.There were no further patient complications.

Manufacturer Narrative

The reported patient symptom of pain is a known risk associated with use of these devices as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent 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
• MDR Report Key: 15523659
• MDR Text Key: 300996434
• Report Number: 2124215-2022-38394
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729992547
• UDI-Public: 08714729992547
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2023
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 0028638584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• 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