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

Model Number	M001394260000450
Medical Device Problem Codes	Stretched (1601); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the explant procedure and outcome, but further information was unable to be obtained.
Event or Problem Description
It was reported via that the coil was stretched and protruding from the target location, requiring explantation.A 45cm embold packing coil was selected for use in an embolization procedure in the 4mm gastroduodenal artery (gda).A 4mm fibered coil was placed distally prior to the placement of this coil.This embold packing coil was placed in the gda without incident.However, upon follow up using ct, the coil was found to be stretched and extending out of the target vessel into the origin of the celiac artery into the proximal aorta and then descending to the right common femoral artery.The coil was scheduled to be explanted on (b)(6) 2025.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the explant procedure and outcome, but further information was unable to be obtained.
Event or Problem Description
It was reported that the coil was stretched and protruding from the target location, requiring explantation.A 45cm embold packing coil was selected for use in an embolization procedure in the 4mm gastroduodenal artery (gda).A 4mm fibered coil was placed distally prior to the placement of this coil.This embold packing coil was placed in the gda without incident.However, upon follow up using ct, the coil was found to be stretched and extending out of the target vessel into the origin of the celiac artery into the proximal aorta and then descending to the right common femoral artery.The coil was scheduled to be explanted on (b)(6) 2025.It was confirmed that the coil was explanted.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22066771
• Report Number: 2124215-2025-32692
• Device Sequence Number: 12894410
• Product Code: KRD
• UDI-Device Identifier: 00191506026608
• UDI-Public: (01)00191506026608(17)270625(10)34308758
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K230706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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: M001394260000450
• Device Catalogue Number: M001394260000450
• Device Lot Number: 0034308758
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/11/2025
• Date Device Manufactured: 06/25/2024
• 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 Age: 71 YR
• Patient Sex: Female