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

Model Number	M001394250020080
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by manufacturer: the device was returned for analysis.Visual examination revealed a stretched and detached coil.The perforations were intact.The introducer sheath was kinked, and a shaft kink was noted on the non-boston scientific microcatheter.Microscopic examination revealed no coupler damage, but the coil was detached at the distal coupler weld.The introducer sheath kink was observed 7 mm from the tip.The non-boston scientific microcatheter shaft kink was observed at the strain relief.X-ray examination revealed a stretched and detached coil inside the hub of the microcatheter.
Event or Problem Description
Reportable based on device analysis completed on (b)(6)2025.A 2x8 embold soft coil was selected for use in an embolization procedure.During the procedure, the coil would not advance though the 2.8f 130cm non-boston scientific microcatheter.The coil was removed through the delivery catheter, and another embold coil was used to complete the procedure.However, device analysis revealed a detached coil.

• 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: 21298256
• Report Number: 2124215-2025-05529
• Device Sequence Number: 9327842
• Product Code: KRD
• UDI-Device Identifier: 00191506026394
• UDI-Public: 00191506026394
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/03/2025

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: M001394250020080
• Device Catalogue Number: M001394250020080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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