MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR II; SNARE, FLEXIBLE

Model Number	M00561241
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: visual evaluation of the returned device revealed that the cautery pin was detached/separated and was not returned by the customer.The lack of cautery pin or conditions of the event failed to determine what could have contributed to the reported failure in order to identify the most probable cause of the event, additionally, during the manufacturing process the units are inspected in order to avoid the failures reported.However, there is no control in how devices are handled in the field.Based on the information available and the analysis performed, the most probable root cause is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii-20mm round stiff snare was used in the common bile duct during a colonoscopy with endoscopic mucosal resection (emr) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, "the cautery pin would not be completely locked and secured, it kept falling out." the procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the cautery pin was detached/separated and was not returned by the customer.

• Brand Name: CAPTIVATOR II
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8316757
• Report Number: 3005099803-2019-00484
• Device Sequence Number: 19098733
• Product Code: FDI
• UDI-Device Identifier: 08714729855927
• UDI-Public: 08714729855927
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K133987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2019

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: 04/18/2020
• Device Model Number: M00561241
• Device Catalogue Number: 6124
• Device Lot Number: 0020543961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1