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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 M00562672
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/02/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a sensation medium oval flexible snare was used during a polypectomy procedure on (b)(6) 2019.According to the complainant, during the procedure, the snare was used to remove the target polyp.They performed a polypectomy and they used a snare to cut the tissue layer.When they were suctioning the polyp through the scope into the trap, a piece of braided metal that is similar to the braided metal of the snare was suctioned up with the polyp.They were concerned that the metal piece was from the snare used, however the snare that they used was still intact.The complainant was unsure where that piece of braided metal came from.The procedure was completed with this device.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Event Description
It was reported to boston scientific corporation that a sensation medium oval flexible snare was used during a polypectomy procedure on (b)(6) 2019.According to the complainant, during the procedure, the snare was used to remove the target polyp.They performed a polypectomy and they used a snare to cut the tissue layer.When they were suctioning the polyp through the scope into the trap, a piece of braided metal that is similar to the braided metal of the snare was suctioned up with the polyp.They were concerned that the metal piece was from the snare used, however the snare that they used was still intact.The complainant was unsure where that piece of braided metal came from.The procedure was completed with this device.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Manufacturer Narrative
Problem code 2944 captures the reportable event of foreign material present in device.Investigation results: a sensation snare was returned for analysis.Visual evaluation of the returned device revealed that a small piece of wire metal was received with the device.The device was visually inspected, however, no damage was found.Risk analysis was performed on the document polypectomy snares risk management workbook and it was confirmed that the reported event is not a new or unanticipated failure mode and does not require to be updated.Based on the information available and the analysis performed, the most probable root cause for this problem is manufacturing deficiency.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.There is an investigation in place to address this issue.
 
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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 Key9244647
MDR Text Key178756001
Report Number3005099803-2019-05133
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729268819
UDI-Public08714729268819
Combination Product (y/n)N
PMA/PMN Number
K131700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/10/2019
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 Date07/18/2022
Device Model NumberM00562672
Device Catalogue Number6267-20
Device Lot Number0024138437
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2019
Initial Date Manufacturer Received 10/04/2019
Initial Date FDA Received10/28/2019
Supplement Dates Manufacturer Received11/18/2019
Supplement Dates FDA Received12/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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