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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 M00562650
Device Problems Break (1069); Failure to Deliver Energy (1211); Entrapment of Device (1212); Retraction Problem (1536); Difficult to Open or Close (2921)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).The complainant was unable to provide the upn and lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.(b)(4).The device has not been received for analysis; therefore, a failure 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 snare was used in the hepatic flexure during an unknown procedure performed on (b)(6) 2018.According to the complainant, during the procedure, a 30mm sensation snare was used for a reasonably large target polyp.The snare loop was unable to successfully retract and it failed to deliver energy.When the snare was eventually released and removed from the patient's anatomy, the snare appears to be broken.The procedure was rescheduled and the patient is expected to return to complete the procedure.Boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available, a supplemental report will be submitted.
 
Event Description
It was reported to boston scientific corporation that a sensation snare was used in the hepatic flexure during an unknown procedure performed on (b)(6) 2018.According to the complainant, during the procedure, a 30mm sensation snare was used for a reasonably large target polyp.The snare loop was unable to successfully retract and it failed to deliver energy.When the snare was eventually released and removed from the patient's anatomy, the snare appears to be broken.The procedure was rescheduled and the patient is expected to return to complete the procedure.Boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information received on december 18, 2018.The name of the procedure is polyp removal.During the procedure, the snare was difficult to close and it failed to deliver energy.Once closed, the snare became embedded in the anatomy of the polyp but was eventually released and removed from the patient's anatomy.The procedure was rescheduled and the patient was expected to return to complete the procedure on (b)(6) 2018.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
H6: problem code 1212 captures the reportable event of snare loop embedded in patient tissue.H10: the device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.H11: b5, d4, e1, e3 and h10 have been updated based on the additional information received on december 18, 2018.
 
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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
MDR Report Key8168797
MDR Text Key130473061
Report Number3005099803-2018-61759
Device Sequence Number1
Product Code FDI
Combination Product (y/n)N
PMA/PMN Number
K941750
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/22/2021
Device Model NumberM00562650
Device Catalogue Number6265S
Device Lot Number0022025892
Was Device Available for Evaluation? No
Date Manufacturer Received12/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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