MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) SENSATION¿ SHORT THROW; SNARE, FLEXIBLE

Model Number	M00560301
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported event of loop failed to cut.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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a sensation large oval snare was used during a polypectomy procedure performed on (b)(6) 2017.According to the complainant, during the procedure the device stopped cutting halfway through the polyp.Although it was reported that the current was on during the attempt to cut; it was also noted that there might have been connection issues.There were no patient complications at the conclusion of this procedure and the patient was reported to be stable.

• Brand Name: SENSATION¿ SHORT THROW
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6347223
• Report Number: 3005099803-2017-00438
• Device Sequence Number: 720373
• Product Code: FDI
• UDI-Device Identifier: 08714729283898
• UDI-Public: (01)08714729283898(17)20190905(10)19671802
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K941750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/30/2017

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: 09/05/2019
• Device Model Number: M00560301
• Device Catalogue Number: 6030
• Device Lot Number: 19671802
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2017
• Initial Report FDA Received Date: 02/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1