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 Scar Tissue (2060); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/06/2021

Event Type  Injury  

Event Description

It was reported that 5 months post water vapor therapy, the patient performed follow up with physician due to persistent benign prostatic hyperplasia (bph) symptoms.The physician performed a cystoscopy and found a thin piece of bridge tissue in front of the normal defect in the prostatic urethra.The patient has no other complications.

Manufacturer Narrative

B5 describe event or problem: event updated to reflect clarification associated with initial report of scar tissue.Based on the information, there was no device performance issue, no treatment but therapeudic decrease response to treatment.The patient may require alternative therapy at the physician discretion.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the device in question.

Event Description

It was reported that 5 months post water vapor therapy, the patient performed follow up with physician due to persistent benign prostatic hyperplasia (bph) symptoms.The physician performed a cystoscopy and found a thin piece of bridge tissue in front of the normal defect in the prostatic urethra.The patient has no other complications.Further information received indicated that the procedure had taken place several months ago, and the delivery device performed as intended during use.It was also clarified that the initial report was not scar tissue but that the tissue looked untreated close to the surface of the mucosa and tissue treated below the surface.There was no treatment decided but it is believed that the physician may discuss removal via transurethral resection (turp) in the future.

• 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 CORPORATATION; 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: 12805045
• MDR Text Key: 280705300
• Report Number: 2124215-2021-35283
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• 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
• Date Manufacturer Received: 11/16/2021
• 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