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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 02/01/2022
Event Type  malfunction  
Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of (b)(6).The exact date of the event is unknown.The provided event date of (b)(6) 2022 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Problem code: (b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-01347 for the associated device information.It was reported to boston scientific corporation that a sensation medium oval flexible snare was used to remove a large polyp in the cecum during a colonoscopy with polypectomy procedure performed on an unknown date.It was reported that during the procedure and inside the patient, the snare would not deliver energy and would not cut.The grounding pads were moved on the patient and still would not work.The snare was securely attached to the active cord.No visible problem was noted with the cautery pin.The procedure was completed with a different snare.There were no patient complications reported as a result of this event.
 
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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 Key13791988
MDR Text Key287432933
Report Number3005099803-2022-01346
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
Report Date 03/16/2022
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 NumberM00562670
Device Catalogue Number6267S
Device Lot Number0028420774
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/21/2022
Initial Date FDA Received03/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/20/2021
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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