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

Model Number	M001394240040150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil broke.The 90% stenosed target lesion was located in a mildly tortuous and mildly calcified lumbar artery.An embold fibered 4x15 was selected to treat an aneurysm.After unpacking the embold, however, it was discovered to be broken at the detachable portion.A new embold was used to complete the procedure, and there were no patient complications as a result of this event.
Event or Problem Description
It was reported that the coil broke.The 90% stenosed target lesion was located in a mildly tortuous and mildly calcified lumbar artery.An embold fibered 4x15 was selected to treat an aneurysm.After unpacking the embold, however, it was discovered to be broken at the detachable portion.A new embold was used to complete the procedure, and there were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the returned device consists of embold delivery system with the wedge lock and the perforations broken.The coil from the complaint was not returned.Visual examination revealed the perforation broken.Microscopic examination revealed no abnormalities or damage.

• Brand Name: EMBOLD? FIBERED
• 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: 22044589
• Report Number: 2124215-2025-30952
• Device Sequence Number: 8880687
• Product Code: KRD
• UDI-Device Identifier: 08714729983576
• UDI-Public: (01)08714729983576(17)270819(10)34666403
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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: M001394240040150
• Device Catalogue Number: M001394240040150
• Device Lot Number: 0034666403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• 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