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	01/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a sensation large oval snare was used in the colon during a polypectomy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the device failed to cut the target polyp while cold snaring.The procedure was completed with a different device using cautery.There were no patient complications reported as a result of this event.It was reported that the patient had ¿no injury¿ at the conclusion of the procedure.
Additional Manufacturer Narrative
Date of event updated.
Event or Problem Description
It was reported to boston scientific corporation that a sensation large oval snare was used in the colon during a polypectomy procedure.According to the complainant, during the procedure, the device failed to cut the target polyp while cold snaring.The procedure was completed with a different device using cautery.There were no patient complications reported as a result of this event.It was reported that the patient had ¿no injury¿ at the conclusion of the procedure.Attempts to obtain additional information regarding this event have been unsuccessful to date.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 - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7269488
• Report Number: 3005099803-2018-00269
• Device Sequence Number: 1893342
• Product Code: FDI
• UDI-Device Identifier: 08714729283898
• UDI-Public: 08714729283898
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2018

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: Physician
• Device Expiration Date: 09/05/2020
• Device Model Number: M00560301
• Device Catalogue Number: 6030
• Device Lot Number: 0021100411
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 02/14/2018
• Supplement Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1