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

Model Number	M00561100
Medical Device Problem Codes	Failure to Cut (2587); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code (a050702) captures the reportable event of (device failure to cut).Device evaluation: the device was discarded; therefore, a technical analysis could not be performed.A review was not completed of the device history records (dhr) for the device.The dhr review cannot be performed as no lot number was reported and a ship history cannot be performed since the lot number was not reported.Based on the event description and information provided by the customer there is not enough evidence to determine whether the loop failure to cut, was due to the physician's technique during the procedure or was related to a device malfunction.For this reason, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a captivator cold snare was used in the colon during a colonoscopy procedure performed on (b)(6) 2026.During the procedure, the physician tried to cut the polyp and the snare was unable to cut cold.The snare was actuating with resistance when trying to open.The procedure was completed with the original device.There were no patient complications reported as a result of this event.

• Brand Name: CAPTIVATOR? COLD
• Common Device Name: SNARE, NON-ELECTRICAL
• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 25017826
• Report Number: 3005099803-2026-01546
• Device Sequence Number: 10294876
• Product Code: FGX
• UDI-Device Identifier: 08714729971252
• UDI-Public: (01)08714729971252
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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
• 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: 04/03/2026
• Initial Report FDA Received Date: 04/28/2026
• 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