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

Model Number	M00561101
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf impact code f2301 captures the reportable event of additional device required.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf device code a0501 captures the reportable event of loop detached.
Event or Problem Description
It was reported to boston scientific corporation that a cold snare was used in the colon during a colonoscopy procedure performed on (b)(6) 2026.It was reported that the procedure took longer because the staff had to withdraw the snare and retrieve it using a grasping forceps.In addition, the snare tip had migrated into the lumen of the gut.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h2 (correction): block b2 (outcomes attrib to adv event) has been updated to address the reported event of unexpected medical intervention.Block h6: imdrf impact code f2301 captures the reportable event of additional device required.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf device code a0501 captures the reportable event of loop detached.Block h11: the device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device; however, response was not received.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Upon analysis, there is insufficient evidence to determine whether the issue resulted from the physician's technique during the procedure or from a device malfunction.Additionally, based on the most relevant information for the complaint including product record review results, the device was found to meet all required manufacturing specifications and passed all controls and inspections, with no abnormalities reported during assembly.However, due to insufficient evidence, a definitive cause for the reported issue cannot be established.Without proper device evaluation, the factors that contributed to the event remain unknown.In addition, the as reported impact codes of "prolonged episode of care", "additional device required" and "unexpected medical intervention" will be classified as "adverse event related to procedure" since the adverse event occurred due to the issues encountered during procedure.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unable to exclude device problem.
Event or Problem Description
It was reported to boston scientific corporation that a cold snare was used in the colon during a colonoscopy procedure performed on (b)(6), 2026.It was reported that the procedure took longer because the staff had to withdraw the snare and retrieve it using a grasping forceps.In addition, the snare tip had migrated into the lumen of the gut.There were no patient complications reported as a result of this event.

• Brand Name: CAPTIVATOR COLD SINGLE-USE SNARE
• 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: 24542361
• Report Number: 3005099803-2026-00862
• Device Sequence Number: 5725199
• Product Code: FGX
• UDI-Device Identifier: 08714729971269
• UDI-Public: (01)08714729971269(17)281013(10)37701760
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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 Model Number: M00561101
• Device Catalogue Number: M00561101
• Device Lot Number: 0037701760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/03/2026
• Date Device Manufactured: 10/14/2025
• 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