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

Model Number	M00562301
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	10/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of detachment of device or device component.
Event or Problem Description
It was reported to boston scientific that a captivator snare was used to remove a polyp during a colonoscopy procedure performed on (b)(6) 2025.During the procedure, the snare disconnected.The snare piece was retrieved from the patient using a forceps.The procedure was completed with a different device.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of detachment of device or device component.Block h11: investigation results the captivator device was not returned as it was reported to be disposed.A technical analysis could not be performed.However, a media analysis was performed on the photos provided by the complainant where it can be observed that the loop detached.No other problems with the device were noted.According to the media analysis performed, it was possible to observe that the loop detached, however, the most probable cause of the reported event of loop detachment cannot be established due to lack of evidence.The product was not returned for analysis as it was reported to be disposed, and a technical analysis could not be performed.The investigation concluded that, without analysis of the device, the most probable root cause of the clinical observations is cause not established.
Event or Problem Description
It was reported to boston scientific that a captivator snare was used to remove a polyp during a colonoscopy procedure performed on (b)(6) 2025.During the procedure, the snare disconnected.The snare piece was retrieved from the patient using a forceps.The procedure was completed with a different device.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of detachment of device or device component.Block h11: the returned captivator snares device was analyzed, and it was noted during visual inspection that the loop was detached.Microscopic inspection was performed, and it was observed that the wire was burned.A photo was attached confirming the analyzed condition.Additionally, the loop was not returned for the analysis.No other problems with the device were noted.The reported event of detachment of device or device component was confirmed.It was found during functional inspection that the loop was detached.Investigation determined that the loop was detached from the device.Microscopic inspection revealed that the wire exhibited burn damage.A supporting image has been attached to confirm the analyzed condition.It is noted that the loop itself was not returned for further analysis.It was concluded that the manufacturing process was capable of ensuring proper loop attachment and integrity at the time of manufacturing of the unit.Based on all available information, the probable root cause assigned is unable to exclude device problem.Block h11: block d4 (model number) has been corrected.
Event or Problem Description
It was reported to boston scientific that a captivator snare was used to remove a polyp during a colonoscopy procedure performed on (b)(6) 2025.During the procedure, the snare disconnected.The snare piece was retrieved from the patient using a forceps.The procedure was completed with a different 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
• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23452422
• Report Number: 3005099803-2025-05773
• Device Sequence Number: 18161215
• Product Code: FDI
• UDI-Device Identifier: 08714729019312
• UDI-Public: (01)08714729019312(17)260705(10)31961824
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K131700
• 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,Followup,Followup
• Report Date (Section B): 02/23/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/05/2026
• Device Model Number: M00562301
• Device Catalogue Number: 6230
• Device Lot Number: 0031961824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 11/07/2025; 01/30/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/24/2025; 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• 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
• Patient Sex: Unknown