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

Model Number	M00562650
Medical Device Problem Codes	Failure to Cut (2587); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a sensation large oval med stiff snare was used during a gastroscopy procedure performed on an unknown date.During a gastroscopy procedure, a gastroenterologist performed a macro biopsy in the gastric fundus area.A 30 mm polypectomy snare was used for the biopsy.The snare was tested, and it opened and closed ok.After closing the snare, the handle of the device detached from the device's body.The snare was unable to cut.Bleeding started, and a hemostatic maneuver was performed.It was not reported what intervention was required.The patient had to return the next day and was taken to the operating room to undergo another hemostatic maneuver.It was not reported what intervention was required.Note: no further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block e1: (initial reporter email) (b)(6).Block h6: imdrf patient code e0506 captures the reportable event of hemorrhage major.Imdrf impact code f08 captures the reportable event of hospitalization.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf device code a050702 captures the reportable event of loop cutting issues.

• 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 DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17208972
• Report Number: 3005099803-2023-03477
• Device Sequence Number: 6666838
• Product Code: FDI
• UDI-Device Identifier: 08714729748069
• UDI-Public: 08714729748069
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K941750
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 06/27/2023

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: 08/24/2025
• Device Model Number: M00562650
• Device Catalogue Number: 6265S
• Device Lot Number: 0030019397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown