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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 Break (1069); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/12/2024
Event Type  malfunction  
Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of snare loop break.
 
Event Description
It was reported to boston scientific corporation that a sensation short throw snare was used during an unknown procedure performed on an unknown date.During the procedure and inside the patient, the device snapped and the wire inside the sheath was all bent.The snare was successfully looped around the polyp.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that a sensation short throw snare was used during an unknown procedure performed on an unknown date.During the procedure and inside the patient, the device snapped and the wire inside the sheath was all bent.The snare was successfully looped around the polyp.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Additional information received on march 13,2024.The procedure performed was colonoscopy.The procedure was performed on (b)(6) 2024.
 
Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of snare loop break.Block h11: blocks b3 (date of event), b5 (describe event or problem), and e1 (initial reporter title and last name) have been updated based on the additional information received on march 13, 2024.
 
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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 Key18880356
MDR Text Key337511561
Report Number3005099803-2024-00995
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729748083
UDI-Public08714729748083
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K941750
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/09/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2024
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 Number0031908187
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/13/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2023
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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