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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 Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/03/2021
Event Type  malfunction  
Event Description
It was reported that during preparation for a convective radiofrequency water vapor thermal therapy, the device was removed from the box and it was noted that the white tyvek paper seal was missing.There was no patient involved when the issue was noted.The procedure was completed using a different device.
 
Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes that the reported event of incomplete seal was not confirmed as no leaks were identified in the syringe packaging and the visual and functional testing performed on the delivery device did not identify any irregularities that could affect the functionality.Device history record (dhr): the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: upon receipt at our post market quality assurance laboratory, this device and syringe package were thoroughly analyzed.There were no leaks observed in the syringe packaging.The device was returned intact.The handle was in overall good physical condition.The external tubing had no kinks.Connecting cable was in good physical condition.The pins in the connector were clean and straight.The syringe luer and saline bag spike were in good condition.All buttons pressed and spring back with no issues.The backplate and top housing of the device were removed for internal visual inspection.The interior was in overall good physical condition.The returned device counter had shown it completed 3 treatment cycles.The retract/deploy functionality and the feel of the buttons were tested 5 times and worked as intended.Water pressure and temperatures during priming were nominal.The device completed the priming and pretreatment sequence with no issues.It was able to complete 5 full treatment cycles (deploy, treatment, and retract) with no issues.There were no leaks found in the device.The device passed functional testing.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Investigation conclusion: based on the information available, a conclusion code of no problem detected was assigned to this investigation.
 
Event Description
It was reported that during preparation for a convective radiofrequency water vapor thermal therapy, the device was removed from the box and it was noted that the white tyvek paper seal was missing.There was no patient involved when the issue was noted.The procedure was completed using a different device.
 
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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 scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer Contact
alyson harris
4100 hamline avenue north
building c
saint paul, MN 55112
4089353452
MDR Report Key12529684
MDR Text Key273299156
Report Number2124215-2021-28835
Device Sequence Number1
Product Code KNS
UDI-Device Identifier08714729992547
UDI-Public08714729992547
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191505
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/07/2023
Device Model NumberD2201
Device Catalogue NumberD2201
Device Lot Number0027400121
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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