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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROFILE; SNARE, FLEXIBLE
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BOSTON SCIENTIFIC CORPORATION PROFILE; SNARE, FLEXIBLE Back to Search Results
Model Number M00562571
Device Problems Failure to Deliver Energy (1211); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(6).H6: imdrf device code a090402 captures the reportable event of device could not deliver energy.
 
Event Description
It was reported to boston scientific corporation that a profile medium oval flexible snare was used during a procedure performed on (b)(6) 2023.During the procedure, the device has no electrical current detected.It was not reported what device was used to complete the procedure.It was not reported if there were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Manufacturer Narrative
Block e1: (initial reporter address (b)(6).Imdrf device code a090402 captures the reportable event of device could not deliver energy block h10: investigation results a profile snare was received for analysis.Visual analysis of the returned device found that the handle part was not returned, the wire had a mechanical cut and the working length was melted and burnt indicating there was cauterization during the procedure which were also noted during microscope inspection.Electrical testing could not be performed due to the condition of the device.The reported event of unable to cauterize and/or apply electrical current was not confirmed.The analysis of the returned device showed that the working length was melted and blackened at the distal end, indicating there was cauterization during the procedure.Most likely, procedural factors such as the handling of the device and the technique used by the physician during initial use, set-up, or shortly thereafter could have affected its condition and led to the reported event.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is adverse event related to procedure.
 
Event Description
It was reported to boston scientific corporation that a profile medium oval flexible snare was used during a procedure performed on (b)(6) 2023.During the procedure, the device has no electrical current detected.It was not reported what device was used to complete the procedure.It was not reported if there were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
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Brand Name
PROFILE
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 Key16751480
MDR Text Key313409999
Report Number3005099803-2023-01776
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729156635
UDI-Public08714729156635
Combination Product (y/n)N
Reporter Country CodeBR
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 Physician
Type of Report Initial,Followup
Report Date 08/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00562571
Device Catalogue Number6257
Device Lot Number0027965225
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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