MAUDE Adverse Event Report: NXTHERA INC. REZUM DELIVERY DEVICE KIT FOR BPH; VAPOR ABLATION SYSTEM

Model Number D2201-C2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysuria (2684); No Code Available (3191)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact event date is unknown.

Event Description

It was reported that approximately 10 weeks post convective radio frequency water vapor thermal therapy procedure of the prostate, the patient has terrible dysuria.Cystoscopy performed by the physician, showed there was a "flap" of tissue.The physician reported that the tissue is possibly attached and that is necrotic and partially in the bladder causing obstruction.No further information was provided.

• Brand Name: REZUM DELIVERY DEVICE KIT FOR BPH
• Type of Device: VAPOR ABLATION SYSTEM
• Manufacturer (Section D): NXTHERA INC.; 7351 kirkwood ln n; suite 138; maple grove MN 55369
• Manufacturer Contact: bertha paulo ; 7351 kirkwood ln n; suite 138; maple grove, MN 55369
• MDR Report Key: 8175579
• MDR Text Key: 130769038
• Report Number: 3007795803-2018-00004
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D2201-C2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2018
• 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