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

Model Number	M00560321
Medical Device Problem Codes	Entrapment of Device (1212); Defective Device (2588)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	12/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.(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 small oval med stiff snare was used during an unknown procedure on (b)(6) 2018.According to the complainant, during the procedure, when the snare was slowly extended, the snare came flying out and went all the way through underneath the mucosa/polyp and created a hematoma.The snare "burrowed" all the way underneath the polyp/mucosa.Reportedly, the snare came out suddenly/unexpectedly and too far and fast and was embedded in the patient's tissue.It was unknown if any treatment or intervention was done to treat the hematoma.The procedure was completed using a different device.The condition of the patient following the procedure was reported to be unknown.Should additional relevant details become available a supplemental report will be submitted.

• 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: 8248722
• Report Number: 3005099803-2019-00047
• Device Sequence Number: 13984513
• Product Code: FDI
• UDI-Device Identifier: 08714729283928
• UDI-Public: 08714729283928
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/15/2019

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
• Operator of Device: Health Professional
• Device Model Number: M00560321
• Device Catalogue Number: 6032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1