MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBOLD? PACKING; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	M001394260000600
Medical Device Problem Codes	Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results: device analysis findings: the returned device consisted of an embold packing delivery system with the perforations intact.The coil was not received.The device was examined visually and microscopically to reveal a coil separation from the distal coupler and a bent distal coupler.Device history record (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause linked to device but unable to trace more specifically.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2026.It was reported that the device prematurely deployed within the patient.An embold? packing 60 was selected for use in an embolization procedure to treat a bleed.During the procedure, the device prematurely deployed within the patient.There were no patient complications as a result of this event.However, device analysis revealed the coil was separated from the distal coupler.

• Brand Name: EMBOLD? PACKING
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 25350637
• Report Number: 2124215-2026-29174
• Device Sequence Number: 10445107
• Product Code: KRD
• UDI-Device Identifier: 00191506026615
• UDI-Public: (01)00191506026615(17)290104(10)38267664
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K230706
• 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
• Report Date (Section B): 06/01/2026

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: M001394260000600
• Device Catalogue Number: M001394260000600
• Device Lot Number: 0038267664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2026
• 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: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2026
• 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
• Patient Sex: Unknown