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

Model Number	M00562551
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).For the reported event of loop failed to cut.Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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 polypectomy procedure performed on (b)(6) 2016.According to the complainant, during a cold snaring procedure, the snare loop failed to cut the target polyp.The physician noticed that the device rotated during retraction.The procedure was completed with this device using cautery.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
Additional Manufacturer Narrative
Investigation results: visual evaluation of the returned device found no anomalies.Functional testing was performed and the device passed the retroflex test, it extends and retracts within specification.Electrical resistance testing was performed and resistance measured at 11.2 ohms, within manufacturing specifications.The device passed the deflection test.The reported complaint that the snare loop failed to cut was not confirmed.Evaluation of the returned device found no evidence of the alleged issues, or any defect which could have contributed to the event.A review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a profile small oval snare was used during a polypectomy procedure performed on (b)(6) 2016.According to the complainant, during a cold snaring procedure, the snare loop failed to cut the target polyp.The physician noticed that the device rotated during retraction.The procedure was completed with this device using cautery.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

• 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: 6110804
• Report Number: 3005099803-2016-03537
• Device Sequence Number: 13640031
• Product Code: FDI
• UDI-Device Identifier: 08714729156659
• UDI-Public: (01)08714729156659(17)20190615(10)19359665
• 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,Followup
• Report Date (Section B): 10/27/2016

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: Physician
• Device Expiration Date: 06/15/2019
• Device Model Number: M00562551
• Device Catalogue Number: 6255
• Device Lot Number: 19359665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2016
• Supplement Report FDA Received Date: 12/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1