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

Model Number	DGN-538
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a0501 captures the reportable event of loop detachment.
Event or Problem Description
It was reported to boston scientific corporation that a rescuenet device was used in the stomach during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2025.During the procedure, the device was sent through the scope, and a blue piece from the rescue net was pushed out of the scope.This piece was then retrieved.The procedure was completed with another rescuenet device.There were no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a0501 captures the reportable event of loop detachment.Block h2: (additional information) block b5 (describe event or problem) and block h6 (device code) have been updated based on the additional information received on may 2, 2025.Block h6 has been updated to code for net torn material, deeming this a non-reportable scenario.
Event or Problem Description
It was reported to boston scientific corporation that a rescuenet device was used in the stomach during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2025.During the procedure, the device was sent through the scope, and a blue piece from the rescue net was pushed out of the scope.This piece was then retrieved.The procedure was completed with another rescuenet device.There were no patient complications have been reported as a result of this event.Additional information received on may 2, 2025: it was clarified that the net was torn.

• Brand Name: RESCUENET?
• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21894711
• Report Number: 3005099803-2025-01825
• Device Sequence Number: 17032408
• Product Code: FDI
• UDI-Device Identifier: 10840253107425
• UDI-Public: (01)10840253107425
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K152580
• 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
• Report Date (Section B): 05/29/2025

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: DGN-538
• Device Catalogue Number: DGN-538
• 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: 04/01/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/29/2025
• 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
• Patient Sex: Unknown