Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Problems Unspecified Infection (1930); Urinary Retention (2119)
Event Date 08/26/2020
Event Type  Injury  
Event Description
It was reported that the patient did not present with an infection during convective radiofrequency water vapor thermal therapy, however the patient suffered an esbl e.Coli infection post procedure and was placed on iv antibiotics.A catheter was placed immediately post procedure but failed a void trial, and a new catheter was placed 1 week post procedure.The patient finished an additional 4 weeks course of iv antibiotics.The patient cultures were negative, however the infection persisted after the treatment.The patient still has irritative symptoms with significant urine urgency and frequency requiring a foley.The physician thinks the infection was catheter-associated.
 
Event Description
It was reported that the patient did not present with an infection during convective radiofrequency water vapor thermal therapy, however the patient suffered an esbl e.Coli infection post procedure and was placed on iv antibiotics.A catheter was placed immediately post procedure but failed a void trial, and a new catheter was placed 1 week post procedure.The patient finished an additional 4 weeks course of iv antibiotics.The patient cultures were negative, however the infection persisted after the treatment.The patient still has irritative symptoms with significant urine urgency and frequency requiring a foley.The physician thinks the infection was catheter-associated.
 
Manufacturer Narrative
The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.The device was not returned for analysis.A review of the product labeling determined that urinary retention and infection are noted as potential adverse events associated with the use of the device.Based on the available information, an evaluation conclusion code of known inherent risk of device was assigned to this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
REZUM
Type of Device
UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
malborough MA 01752
MDR Report Key10886347
MDR Text Key218956809
Report Number2937094-2020-01004
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 health professional,user faci
Type of Report Initial,Followup
Report Date 12/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2020
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 Received12/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age79 YR
Patient Weight72
-
-