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U.S. Department of Health and Human Services

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

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NXTHERA INC. REZUM DELIVERY DEVICE KIT FOR BPH VAPOR ABLATION SYSTEM Back to Search Results
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.
 
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Brand NameREZUM DELIVERY DEVICE KIT FOR BPH
Type of DeviceVAPOR 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 Key8175579
MDR Text Key130769038
Report Number3007795803-2018-00004
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180237
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
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 Received12/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberD2201-C2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2018
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 Treatment Data
Date Received: 12/18/2018 Patient Sequence Number: 1
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