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

Model Number	M001394260000450
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601); Positioning Problem (3009)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the catheter kicked-back upon coil packing, and the coil broke upon removal.This patient was receiving embolization treatment for bleeding in the gastric artery.During the procedure, a 3 mm embold fibered coil delivered then the rest was filled in with this 45cm embold packing coil.The coil was advanced easily into the artery, but during packing, the coil pushed the microcatheter out of the vessel.The coil was attempted to be retracted, but the coil unraveled/stretched and was unable to be pulled all the way back into the microcatheter and eventually broke.The coil was partially explanted, and a portion still remains inside the patient.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that the catheter kicked-back upon coil packing, and the coil broke upon removal.This patient was receiving embolization treatment for bleeding in the gastric artery.During the procedure, a 3 mm embold fibered coil delivered then the rest was filled in with this 45cm embold packing coil.The coil was advanced easily into the artery, but during packing, the coil pushed the microcatheter out of the vessel.The coil was attempted to be retracted, but the coil unraveled/stretched and was unable to be pulled all the way back into the microcatheter and eventually broke.The coil was partially explanted, and a portion still remains inside the patient.There were no patient complications as a result of this event.Additional information indicated that a snare was attempted to be used to remove the portion that remained inside the patient, and it ended up pushing coil into parent vessel.

• 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: 22188713
• Report Number: 2124215-2025-37741
• Device Sequence Number: 8356780
• Product Code: KRD
• UDI-Device Identifier: 00191506026608
• UDI-Public: (01)00191506026608(17)270701(10)34349143
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: 0034349143
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/22/2025
• Date Device Manufactured: 07/01/2024
• 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 Sex: Unknown