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

Model Number	M001394250020040
Medical Device Problem Codes	Difficult to Remove (1528); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil migrated post deployment.A 2mm x 4cm embold soft coil was selected for use in a prostatic artery embolization (pae) procedure.The vessel was 2-3mm, and the tortuosity was moderate to severe.During the procedure, the coil could not be retracted back into the microcatheter.The coil was deployed, and it was considered successful, but afterwards the coil moved out of position into the superior gluteal artery.The coil was pulled out with the sheath.After retrieving the coil, the physician decided to close and come back another day given the events.Only one side of the procedure was treated successfully; this side was not.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that the coil migrated post deployment.A 2mm x 4cm embold soft coil was selected for use in a prostatic artery embolization (pae) procedure.The vessel was 2-3mm, and the tortuosity was moderate to severe.During the procedure, the coil could not be retracted back into the microcatheter.The coil was deployed, and it was considered successful, but afterwards the coil moved out of position into the superior gluteal artery.The coil was pulled out with the sheath.After retrieving the coil, the physician decided to close and come back another day given the events.Only one side of the procedure was treated successfully; this side was not.There were no patient complications as a result of this event.

• Brand Name: EMBOLD? SOFT
• 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: 22668553
• Report Number: 2124215-2025-51163
• Device Sequence Number: 3824791
• Product Code: KRD
• UDI-Device Identifier: 00191506026370
• UDI-Public: (01)00191506026370(17)270516(10)34045230
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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: M001394250020040
• Device Catalogue Number: M001394250020040
• Device Lot Number: 0034045230
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 12/02/2025
• Date Device Manufactured: 05/16/2024
• 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
• Patient Sex: Unknown