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

Model Number	M00561191
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a 25mm round stiff captivator ii snare was used during an endoscopic mucosal resection procedure performed on (b)(6) 2021.It was reported that during the preparation and outside the patient there was a connection problem with the active cord connector.It was noticed that the cautery pin was detached and the width of the pin was closed.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Initial reporter state is (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a 25mm round stiff captivator ii snare was used during an endoscopic mucosal resection procedure performed on (b)(6) 2021.It was reported that during the preparation and outside the patient there was a connection problem with the active cord connector.It was noticed that the cautery pin was detached and the width of the pin was closed.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter state is fukuoka prefecture.Block h6: medical device problem code a0501 captures the reportable event of cautery pin detached.Block h10 investigation results: one captivator snare was received for analysis.Visual analysis of the returned device found no device problems.Dimensional test was also performed and the 2 in 1 was compared with the active cord gauge and it was out of the expected measurement.The reported event of "cautery pin detached" could not be confirmed since the cautery pins were not detached upon device analysis.The reported event of "device interaction with another device" was confirmed since upon product analysis, it was observed that two in one connector (cautery pin) was smaller (od) than expected.For this reason, the user encountered connection problems.However, the manufacturing process have quality control processes to confirm the correct size of the 2 in 1 connector during the manufacturing process.So, it's unknown if the device was damaged during preparation or during any other moment.Based on the analysis of the returned device and the information available, the most probable cause of the reported event is cause not established since it cannot be established due to lack of evidence.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

• Brand Name: CAPTIVATOR II
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13252186
• Report Number: 3005099803-2021-08150
• Device Sequence Number: 4431868
• Product Code: FDI
• UDI-Device Identifier: 08714729855934
• UDI-Public: 08714729855934
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2022

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: 08/03/2024
• Device Model Number: M00561191
• Device Catalogue Number: 6119
• Device Lot Number: 0027759116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown