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

Model Number	M001394260000150
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported per medwatch (b)(4) that the coil broke and the filament remained in the microcatheter.An embold packing 15 was selected for an artery embolization procedure.When advancing the delivery wire through the microcatheter, however, the coil detached without using the deployment mechanism.When the microcatheter was removed, part of the coil filament was still in the lumen of the microcatheter.Two subsequent arteries were selected and embolized then upon attempted removal of base catheter, the wire was unable to be advanced past the tip of the base catheter, and when removing the catheter, the coil filament was observed to be protruding from the tip of the catheter.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
A6 - race: corrected.H10 - related report number: corrected.
Event or Problem Description
It was reported per medwatch (b)(4) that the coil broke and the filament remained in the microcatheter.An embold packing 15 was selected for an artery embolization procedure.When advancing the delivery wire through the microcatheter, however, the coil detached without using the deployment mechanism.When the microcatheter was removed, part of the coil filament was still in the lumen of the microcatheter.Two subsequent arteries were selected and embolized then upon attempted removal of base catheter, the wire was unable to be advanced past the tip of the base catheter, and when removing the catheter, the coil filament was observed to be protruding from the tip of the catheter.There were no patient complications as a result of this event.

• 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: 23571122
• Report Number: 2124215-2025-82599
• Device Sequence Number: 18672033
• Product Code: KRD
• UDI-Device Identifier: 00191506026585
• UDI-Public: (01)00191506026585(17)280306(10)36013980
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/12/2025

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: M001394260000150
• Device Catalogue Number: M001394260000150
• Device Lot Number: 0036013980
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/12/2025
• Date Device Manufactured: 03/07/2025
• 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: Male
• Patient Race: White