MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR¿ COLD; SNARE, NON-ELECTRICAL

Model Number	M00561100
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: upon opening snare from packaging to prepare for case, the device buckled and was not functional.

• Brand Name: CAPTIVATOR¿ COLD
• Common Device Name: SNARE, NON-ELECTRICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 24895125
• Report Number: 24895125
• Device Sequence Number: 21451748
• Product Code: FGX
• UDI-Device Identifier: 08714729971252
• UDI-Public: (01)08714729971252
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2026
• Report Date (Section F): 04/07/2026

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 Model Number: M00561100
• Device Catalogue Number: M00561100
• Device Lot Number: 37816095
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Date Report Sent to FDA: 04/07/2026