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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 M00562670
Device Problems Failure to Deliver Energy (1211); Failure to Cut (2587)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/25/2023
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a sensation short throw was used during a polypectomy procedure performed on (b)(6) 2023.During the procedure, after the sensation snare was inserted into the scope and connected to the generator, physician tried to activate the energy to cut the polyp; however, there was no response or heat, and the snare could not cut the polyp.The procedure was completed with another sensation snare.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
Imdrf device code a090402 captures the reportable event of snare unable to deliver energy.Imdrf device code a050702 captures the reportable event of snare failure to cut the polyp.
 
Manufacturer Narrative
Imdrf device code (b)(4) captures the reportable event of snare unable to deliver energy.Imdrf device code (b)(4) captures the reportable event of snare failure to cut the polyp.Block h10: investigation results a captivator medium hexagonal stiff snare was received for analysis.Visual inspection of the returned device revealed no damages were found.The 2 in 1 connector passed dimensional testing.Electrical testing was performed, and the device was found within specification.No other problems were noted.The reported complaint of device failure to deliver energy and failure to cut could not be confirmed, since the device passed the electrical test, and the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected since the reported complaint cannot be confirmed.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Block h11: correction to block g1 (mfr site facility name and mfr site address 2) the initial mdr.
 
Event Description
It was reported to boston scientific corporation that a sensation short throw was used during a polypectomy procedure performed on (b)(6) 2023.During the procedure, after the sensation snare was inserted into the scope and connected to the generator, physician tried to activate the energy to cut the polyp; however, there was no response or heat, and the snare could not cut the polyp.The procedure was completed with another sensation snare.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
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 Key16930992
MDR Text Key315208016
Report Number3005099803-2023-02580
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729748083
UDI-Public08714729748083
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K941750
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 07/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00562670
Device Catalogue Number6267S
Device Lot Number0028270137
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/20/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/26/2021
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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