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

Model Number	M00561100
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of snare loop detached block h11: the device was not returned for analysis; therefore, a product analysis could not be performed.For this reason and due to the lack of evidence, it is unable to confirm the reported event.It was confirmed this device met manufacturing specifications prior to distribution, and there were no manufacturing deviations which could have contributed to the reported event.Based on the event description and information provided by the customer, there is not enough evidence to determine whether the loop detachment of the device or device component was due to the physician's technique during the procedure or was related to a device malfunction.Without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Also, the evidence from the product record review did not identify a potential product quality problem or new patient harm.Based on a thorough review of the reported complaint, 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 cold snare device was used for polypectomy during a colonoscopy procedure performed on (b)(6) 2026.During the procedure, a metal piece of the snare came out of the plastic.The procedure was completed with another cold snare device.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

• 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: 25021462
• Report Number: 3005099803-2026-01551
• Device Sequence Number: 18741789
• Product Code: FGX
• UDI-Device Identifier: 08714729971252
• UDI-Public: (01)08714729971252(17)290120(10)38398646
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: 510K 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: Nurse
• 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
• Device Lot Number: 0038398646
• 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: 04/01/2026
• Initial Report FDA Received Date: 04/28/2026
• Date Device Manufactured: 01/21/2026
• 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