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)
Date of Event	05/30/2017
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).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 in the colon during a cold polypectomy procedure performed on (b)(6) 2017.According to the complainant, after withdrawing the device post procedure, it was noted that the snare loop was damaged with visible wire fragments.The procedure was completed with this device.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
Visual evaluation of the returned device found that the snare loop and the snare wire were in good condition.A wire fragment returned with the device was determined to not be a component of the complaint device, as no anomalies were found.Functional testing was performed and the device passed the retroflex test, it extends and retracts within specification.The complaint that the snare loop was broken was not confirmed.Evaluation of the returned device found no evidence of either the alleged issue 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.
Event or Problem Description
It was reported to boston scientific corporation that a sensation medium crescent snare was used in the colon during a cold polypectomy procedure performed on (b)(6) 2017.According to the complainant, after withdrawing the device post procedure, it was noted that the snare loop was damaged with visible wire fragments.The procedure was completed with this device.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: 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: 6654562
• Report Number: 3005099803-2017-01831
• Device Sequence Number: 19120145
• Product Code: FDI
• UDI-Device Identifier: 08714729283935
• UDI-Public: (01)08714729283935(17)20200203(10)20247540
• 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): 05/30/2017

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: 02/03/2020
• Device Model Number: M00560331
• Device Catalogue Number: 6033
• Device Lot Number: 20247540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 06/28/2017
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 07/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1