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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number D2201
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 04/26/2019
Event Type  Injury  
Manufacturer Narrative
Dr.(b)(6).
 
Event Description
The patient underwent a convective radiofrequency water vapor thermal therapy procedure of the prostate.During procedure the patient was administered a prostate blocker for pain and a few minutes later the procedure began.It was reported by the patient that the procedure was extremely painful.The physician continued with the procedure, and it is believed that nine injections were given.The patient remained with a leg bag catheter for ten days post procedure and with little instructions.The catheter was removed, and the patient thought things would improve but did not.The patient returned to the physician and was told that procedure results takes time.The patient returned to the physician four months post procedure, and the physician stated that it was not doing badly after 4 weeks.The patient corrected the physician by clarifying that it has been four months since the procedure.The physician performed a cystoscopy and stated that the procedure did not work.The physician recommended the patient to try photovaporization (pvp) laser treatment.The patient did not schedule with the physician and had nothing further done.The patients issues have slightly improved but is getting worse.
 
Manufacturer Narrative
(b)(6).The device is not available for analysis.A review of the ifu and operators manual was completed and did not reveal any evidence of device misuse, off-label use, or failure to follow instructions.Based on review of the information available, pain is known risk associated with the use of the device and is noted as such in the instruction for use (ifu).An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.
 
Event Description
The patient underwent a convective radiofrequency water vapor thermal therapy procedure of the prostate.During procedure the patient was administered a prostate blocker for pain and a few minutes later the procedure began.It was reported by the patient that the procedure was extremely painful.The physician continued with the procedure, and it is believed that nine injections were given.The patient remained with a leg bag catheter for ten days post procedure and with little instructions.The catheter was removed, and the patient thought things would improve but did not.The patient returned to the physician and was told that procedure results takes time.The patient returned to the physician four months post procedure, and the physician stated that it was not doing badly after 4 weeks.The patient corrected the physician by clarifying that it has been four months since the procedure.The physician performed a cystoscopy and stated that the procedure did not work.The physician recommended the patient to try photovaporization (pvp) laser treatment.The patient did not schedule with the physician and had nothing further done.The patients issues have slightly improved but is getting worse.
 
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Brand Name
REZUM
Type of Device
UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scienitific way
marlborough MA 01752
MDR Report Key10473747
MDR Text Key205114801
Report Number2937094-2020-00788
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
PMA/PMN Number
K180237
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 09/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberD2201
Device Catalogue NumberD2201
Was Device Available for Evaluation? No
Date Manufacturer Received09/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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