MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSATION SHORT THROW; SNARE, FLEXIBLE

Model Number	M00562690
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	05/04/2026
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).Block h6: imdrf impact code (f2301) captures the event of (additional device required).Device evaluation: the device was discarded; therefore, a technical analysis could not be performed.A review was completed of the device history records (dhr) for the device.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.Based on the event description and information provided by the customer there is not enough evidence to determine whether the loop detachment of device or device component was due to the physicians technique during the procedure or was related to a device malfunction.For this reason, cause not established is selected as the most probable cause for this event.Additionally, the as reported impact code of "additional device required" will be classified as "adverse event related to procedure" since the adverse event occurred due to the issues encountered during procedure.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 sensation snare was used in the colon during a colonoscopy procedure performed on (b)(6) 2026.During the procedure, when the physician found a polyp, the snare loop detached completely of the working length.As a result, rat tooth forceps was required to retrieve the piece from the patient.The procedure was completed with an alternative device.There were no patient complications reported as a result of this event.

• Brand Name: SENSATION SHORT THROW
• 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: 25303095
• Report Number: 3005099803-2026-02152
• Device Sequence Number: 9517776
• Product Code: FDI
• UDI-Device Identifier: 08714729748106
• UDI-Public: (01)08714729748106(17)290208(10)38561342
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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: M00562690
• Device Catalogue Number: M00562690
• Device Lot Number: 0038561342
• 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: 05/04/2026
• Initial Report FDA Received Date: 05/27/2026
• Date Device Manufactured: 02/09/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown