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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 M00562651
Device Problems Failure to Deliver Energy (1211); Entrapment of Device (1212); Failure to Cut (2587)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2021
Event Type  Injury  
Event Description
It was reported to boston scientific corporation that a sensation large oval med stiff snare was used in the colon during a colonoscopic polypectomy procedure performed on (b)(6) 2021.During the procedure, the snare did not energize and the device could not remove the target polyp.It was noted that the snare loop was embedded into the polyp.The snare was cut and removed using biopsy forceps.The procedure was completed through multiple small resections using another sensation snare.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
(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
It was reported to boston scientific corporation that a sensation large oval med stiff snare was used in the colon during a colonoscopic polypectomy procedure performed on (b)(6) 2021.During the procedure, the snare did not energize and the device could not remove the target polyp.It was noted that the snare loop was embedded into the polyp.The snare was cut and removed using biopsy forceps.The procedure was completed through multiple small resections using another sensation snare.There were no patient complications reported as a result of this event.Additional information received on january 17, 2022.After the first snare was cut and removed using biopsy forceps, a second sensation snare was used and was unable to be energized even with the physician changing the power setting.The procedure was completed with a third sensation snare.There were no patient complications.Note: this report pertains to the first of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2021-08192 and 3005099803-2022-00545 for the associated device information.
 
Manufacturer Narrative
Block h6: problem code a150208 captures the reportable event of snare loop entrapment.Problem code a050702 captures the reportable event of snare unable to cut the target polyp.Conclusion code d17 is being used in lieu of an adequate conclusion code for "device not returned." block h10: 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.Block h11: blocks b5 has been updated based on the additional information received on january 17, 2022.
 
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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 Key13255551
MDR Text Key288995581
Report Number3005099803-2021-08192
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729158110
UDI-Public08714729158110
Combination Product (y/n)N
Reporter Country CodeCH
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 02/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/12/2024
Device Model NumberM00562651
Device Catalogue Number6265
Device Lot Number0026956694
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/17/2021
Initial Date FDA Received01/13/2022
Supplement Dates Manufacturer Received01/17/2022
Supplement Dates FDA Received02/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/13/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age37 YR
Patient SexFemale
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