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

Model Number	M00562531
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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 profile small oval snare was used during a colonic polypectomy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, while performing a cold polypectomy the snare loop failed to retract.They were unable to cut the polyp and the plastic sheath bent.The procedure was completed with this device after applying cautery.There were no patient complications reported as a result of this event.

• Brand Name: PROFILE¿
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6228873
• Report Number: 3005099803-2016-04013
• Device Sequence Number: 520957
• Product Code: FDI
• UDI-Device Identifier: 08714729156628
• UDI-Public: (01)08714729156628(17)20190905(10)0019679914
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 12/12/2016

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: M00562531
• Device Catalogue Number: 6253
• Device Lot Number: 0019679914
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2016
• Initial Report FDA Received Date: 01/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1