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

Model Number	M00561291
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	07/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf patient code e2114 captures the reportable event of perforation.Imdrf impact code f2301 captures the reportable event of additional device required.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2024.During the procedure, after just a slight opening of the handle, the whole snare came out of the sheath.The procedure was completed with another captivator snare device.The patient experienced perforation and the patient's condition at the conclusion of the procedure was reported to be fully recovered.

• 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 CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20041195
• Report Number: 3005099803-2024-04071
• Device Sequence Number: 8126522
• Product Code: FDI
• UDI-Device Identifier: 08714729645801
• UDI-Public: 08714729645801
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K202478
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M00561291
• Device Catalogue Number: 6129
• Device Lot Number: 0032822229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 08/22/2024
• Date Device Manufactured: 11/09/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown