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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); Failure to Cut (2587); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/25/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).(b)(4).Investigation results: a sensation large oval med stiff snare was received for analysis.Visual inspection of the returned device revealed that the 2 in 1 connector and the handle cannula was detached.It is most likely that this condition contributed to the failure of delivering energy and this led to difficulties in cutting tissue.No other issues were noted.Since the device has the 2 in 1 connector and the handle cannula detached, these suggest that the assembly process was not performed as per procedure.Based on the information available and the analysis performed, the most probable root cause classification is manufacturing deficiency.A review of the potential causes and controls of the related failure was completed.Based on this review, this complaint does not represent a new or unanticipated event.A labelling review was performed and there was no evidence that the device was used in a manner inconsistent with the labeling or that suggests that there is an issue with the translation, wording, or graphics.There is an investigation in place to address this issue.
 
Event Description
It was reported to boston scientific corporation that a sensation large oval med stiff snare was prepared for use in the rectum during an endoscopic mucosal resection (emr) procedure on (b)(6), 2019.According to the complainant, when the device entered the cargo inspection channel and inside the patient, the device failed to deliver energy upon opening, so it failed to cut the target polyp.Reportedly, there were no visible issues noted with the cautery pin and the snare was securely attached to the active cord.The procedure was completed with another sensation snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the 2 in 1 connector was detached.
 
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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 Key9179071
MDR Text Key173215569
Report Number3005099803-2019-04776
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 company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 10/11/2019
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 Expiration Date03/02/2021
Device Model NumberM00562651
Device Catalogue Number6265
Device Lot Number0021813903
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/19/2019
Initial Date FDA Received10/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2018
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 Age53 YR
Patient Weight56
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