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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HURRICANE RX; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION HURRICANE RX; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number M00545940
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/22/2023
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was used during a procedure performed on (b)(6) 2023.The anatomy location of the procedure is unknown and is being reported as it may have occurred in the esophagus.During the procedure, it was reported that the device leaked from the balloon part.It is unknown how the procedure was completed.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
 
Manufacturer Narrative
Block h6: imdrf device code a0504 captures the reportable event of a balloon leaked at an unknown anatomy location and unknown procedure.
 
Event Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was used during a procedure performed on (b)(6) 2023.The anatomy location of the procedure is unknown and is being reported as it may have occurred in the esophagus.During the procedure, it was reported that the device leaked from the balloon part.It is unknown how the procedure was completed.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
 
Manufacturer Narrative
Block h6: imdrf device code a0504 captures the reportable event of a balloon leaked at an unknown anatomy location and unknown procedure.Block h10: investigation results: the returned hurricane rx dilatation balloon was analyzed, and a visual examination found that the balloon and the catheter of the device had no damage.Functional analysis was performed, and the balloon was inflated and able to hold pressure without any problem.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon leaked was not confirmed.The returned device was in good condition with the capability of being inflated and holding pressure without evidence of leaking.There was no evidence of any damages or issues that would indicate a problem with the device.Therefore, the most probable root cause is no problem detected.
 
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Brand Name
HURRICANE RX
Type of Device
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
cork business technology park
model farm road
cork T12 Y K88
EI   T12 YK88
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key17745200
MDR Text Key323397770
Report Number3005099803-2023-04899
Device Sequence Number1
Product Code FGE
UDI-Device Identifier08714729283850
UDI-Public08714729283850
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K001338
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00545940
Device Catalogue Number4594
Device Lot Number0031404265
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/23/2023
Initial Date FDA Received09/14/2023
Supplement Dates Manufacturer Received11/24/2023
Supplement Dates FDA Received12/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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