MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSATION SHORT THROW; SNARE, FLEXIBLE

Model Number	M00560331
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned sensation short throw was analyzed, and a visual evaluation noted that the loop was broken with evidence of a burned wire.The working length was measured and was found to be within specification.No other visual failures were noted.The investigation findings revealed the loop was broken, consequently confirming the reported event "wire broke".The investigation concluded that the observed failure was likely due to factors encountered during the procedure.It may be that how the device was handled or manipulated and/or the technique used by the physician during initial use of set-up or power-up, limited the performance of the device and contributed to the broken loop.Additionally, the broken loop may occur due to an excessive application of power during the cauterization process; the loop may overheat causing it to break.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a sensation short throw was used during a procedure performed on (b)(6) 2020.According to the complainant, during preparation, the wire broke off when the snare handle was manipulated before the procedure.The procedure was completed with another sensation short throw.There were no patient complications reported as a result of this event.

• Brand Name: SENSATION SHORT THROW
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10952589
• Report Number: 3005099803-2020-05923
• Device Sequence Number: 19554465
• Product Code: FDI
• UDI-Device Identifier: 08714729283935
• UDI-Public: 08714729283935
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/12/2022
• Device Model Number: M00560331
• Device Catalogue Number: 6033
• Device Lot Number: 0024262000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1