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

Model Number	M00560301
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: the exact date of the event is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.However, the complainant stated that the device was used prior to the expiration date.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a sensation large oval med stiff snare was used in the bowel area during a polypectomy procedure performed on unknown date.According to the complainant, during the procedure and inside the patient, they had issues with the sensation 30mm snare not cutting through the target polyps.Reportedly, they were not sure if the snare was securely attached to the active cord and no visible issues were noted with the cautery pins.It created a significant delay which took for almost an hour longer with the procedure time because the cutting wire was stuck in the patient's tissue.This device was used to complete the procedure.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine.

• 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: 10362724
• Report Number: 3005099803-2020-03069
• Device Sequence Number: 16746289
• Product Code: FDI
• UDI-Device Identifier: 08714729283898
• UDI-Public: 08714729283898
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2020

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 Model Number: M00560301
• Device Catalogue Number: 6030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1