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

Model Number	M001394250040300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device eval by manufacturer: the returned device consisted of a soft coil.The delivery system and coil coupler were not returned.The returned device was examined microscopically to reveal a stretched and broken coil.
Event or Problem Description
It was reported that the coil broke.A 4mm x 30cm embold soft coil was selected for use in the embolization of a pseudoaneurysm.During the procedure, the coil detached and disintegrated as it was being recaptured.A lot of fibered threads came apart.The coil was snared, and the base catheter was removed.The procedure was completed with an alternate device.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: 22543492
• Report Number: 2124215-2025-47620
• Device Sequence Number: 7000804
• Product Code: KRD
• UDI-Device Identifier: 00191506026479
• UDI-Public: (01)00191506026479(17)270523(10)34095662
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 07/17/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: M001394250040300
• Device Catalogue Number: M001394250040300
• Device Lot Number: 0034095662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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