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

Model Number	M00560331
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 sensation medium crescent snare was used during an endoscopic mucosal resection (emr) procedure.According to the complainant, during the procedure, the snare loop broke when current was delivered.It was also noted that the snare could not be securely attached to the active cord.The procedure was completed with another sensation snare.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Investigation results: visual evaluation of the returned device found that the loop was smashed with evidence of being burned and the wire was kinked in the middle portion of the device.Functional testing could not be performed due to the condition of the returned device.The cautery pin was inspected and it's measurements were found to be out of manufacturing specification.The review and analysis of all available information failed to indicate a definitive root cause of this complaint.A review of the device history record (dhr) was performed and no deviations were found.
Event or Problem Description
It was reported to boston scientific corporation that a sensation medium crescent snare was used during an endoscopic mucosal resection (emr) procedure.According to the complainant, during the procedure, the snare loop broke when current was delivered.It was also noted that the snare could not be securely attached to the active cord.The procedure was completed with another sensation snare.There were no patient complications reported as a result of this event.

• 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: 6258559
• Report Number: 3005099803-2017-00061
• Device Sequence Number: 452893
• Product Code: FDI
• UDI-Device Identifier: 08714729283935
• UDI-Public: (01)08714729283935(17)20190831(10)0019646101
• 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): 12/27/2016

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: 08/31/2019
• Device Model Number: M00560331
• Device Catalogue Number: 6033
• Device Lot Number: 0019646101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2017
• Supplement Report FDA Received Date: 03/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1