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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSATION SHORT THROW; SNARE, FLEXIBLE
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BOSTON SCIENTIFIC CORPORATION SENSATION SHORT THROW; SNARE, FLEXIBLE Back to Search Results
Model Number M00560311
Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2024
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a sensation short throw snare was used during an unknown procedure performed on (b)(6) 2024.During the procedure and outside the patient, there was a connection problem with the active cord connector.The cautery pin got detached.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of cautery pin detached.
 
Event Description
It was reported to boston scientific corporation that a sensation short throw snare was used during an unknown procedure performed on (b)(6) 2024.During the procedure and outside the patient, there was a connection problem with the active cord connector.The cautery pin got detached.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of cautery pin detached.Block h10 investigation results: one sensation snare was received for analysis.Visual analysis of the returned device revealed no problems.Microscopic inspection was performed, the 2 in 1 connector was carefully inspected, and no problems were found either.Additionally, the device was tested with a boston scientific active cord and the device was connected properly.Also, the device was plugged with non-bsi active cord (conmed and erbe) and the cables were connected properly.Besides that, an electrical test was performed, and the device was found within specification.No problems were noted.The reported event of "cautery pin detachment of device or device component" could not be confirmed.The device was returned without any problems on it.There was no evidence of a manufacturing problem, design or user problem which could have caused the complaint.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is no problem detected.This code was selected since the reported event could not be confirmed.
 
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Brand Name
SENSATION SHORT THROW
Type of Device
SNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
2546 calle primera
propark, coyol
alajuela
CS  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key18740947
MDR Text Key336668768
Report Number3005099803-2024-00598
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729283904
UDI-Public08714729283904
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00560311
Device Catalogue Number6031
Device Lot Number0032064414
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received03/05/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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