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 Fistula (1862); Loss of consciousness (2418); Fluid Discharge (2686)

Event Date 08/01/2022

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact event date is unknown.

Event Description

It was reported by a physician that he had a patient that was admitted to the hospital where it was discovered that he developed a rectal fistula post water vapor therapy procedure.The patient was discharged from the hospital but was re-admitted to the hospital after being found unresponsive.The physician further reported that he followed the correct protocol.The physician indicated that he did not deploy the delivery device needle straight down into the patient s median lobe but rather aimed at a 45 degree angle.The patient did have a smaller prostate gland.The gland was approximately 30g, and the patient did complain of mucus prior to the procedure.The patient is now being seen by another physician who surgically fixed the patient's fistula which was located toward the apex of the prostate.It is the physician s opinion that the water vapor therapy treatment to the prostate median lobe contributed to the rectal fistula.

Event Description

It was reported by a physician that he had a patient that was admitted to the hospital where it was discovered that he developed a rectal fistula following water vapor therapy procedure.The patient was discharged from the hospital but was re-admitted to the hospital after being found unresponsive.The physician further reported that he followed the correct protocol; he indicated that he did not deploy the delivery device needle straight down into the patient's median lobe but rather aimed at a 45 degree angle.The patient did have a smaller prostate gland.The gland was approximately 30g, and the patient did complain of mucus prior to the procedure.The patient is now being seen by another physician who surgically fixed the fistula, located toward the apex of the prostate.The second physician reportedly expressed the opinion that the water vapor therapy treatment to the prostate median lobe contributed to the rectal fistula.Despite good faith efforts, no further information regarding device performance, procedure details, or patient status pre- and post-procedure could be obtained.

Manufacturer Narrative

There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.There is insufficient information to make an adequate assessment on if or how the unresponsive episode which led to another hospitalization is related to the rezum device and/or procedure.The reported patient symptoms of fluid discharge, loss of consciousness, and fistula requiring surgical repair are known risks associated with water vapor therapy procedures and are noted as such in the device instructions for use.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: 15287520
• MDR Text Key: 298559042
• Report Number: 2124215-2022-32229
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 08/24/2022
• Supplement Dates Manufacturer Received: 09/19/2022
• Supplement Dates FDA Received: 09/29/2022
• 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): Hospitalization; Other; Required Intervention