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

Model Number	DGN-538
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a020503 captures the reportable event of seal compromised.
Event or Problem Description
It was reported to boston scientific corporation that a rescuenet disposable retrieval device was inspected on january 15, 2026.During unpacking of the device, it was observed that the seal was peeled off.There were no patient involvements.
Additional Manufacturer Narrative
Block h6: imdrf device code a020503 captures the reportable event of seal compromised.Block h11: the returned rescuenet was analyzed, and during visual inspection, it was found that one box seal was peeled.It is important to mention that the box had remnants of the ink of the seal, which indicates that the seal was originally sticked to it sealing the box.No other problems with the device were noted.It was confirmed this device met manufacturing specifications prior to distribution, and there were no manufacturing deviations which could have contributed to the reported event.The reported event of seal compromised was confirmed.It was found that one box seal was peeled.This problem likely has occurred due to the manner in which the box was transported and manipulated on its way to the storage to wait until the devices could be used; this may have caused the reported and encountered failure.Excessive manipulation of the box without enough care could have induced the defect found.Based on all available information, the probable root cause assigned is unable to exclude device problem.
Event or Problem Description
It was reported to boston scientific corporation that a rescuenet disposable retrieval device was inspected on january 15, 2026.During unpacking of the device, it was observed that the seal was peeled off.There were no patient involvements.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24260347
• Report Number: 3005099803-2026-00452
• Device Sequence Number: 15840338
• Product Code: FDI
• UDI-Device Identifier: 10840253107425
• UDI-Public: (01)10840253107425(17)281203(10)38112298
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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
• Device Lot Number: 0038112298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2025
• 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