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

Model Number	M001394260000600
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil broke.A 60cm embold? packing coil was selected for use in the embolization of a hepatic bleed.The vessel was moderately tortuous.During the procedure, the coil was unable to advance through the microcatheter.The coil made it to the middle/distal portion of the microcatheter before it could not advance any further.There was resistance during advancement and retraction, and the coil broke inside the microcatheter.The coil broke off from the distal coupler.The coil was removed together with the microcatheter.The procedure was completed with another embold? coil of the same size.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that the coil broke.A 60cm embold? packing coil was selected for use in the embolization of a hepatic bleed.The vessel was moderately tortuous.During the procedure, the coil was unable to advance through the microcatheter.The coil made it to the middle/distal portion of the microcatheter before it could not advance any further.There was resistance during advancement and retraction, and the coil broke inside the microcatheter.The coil broke off from the distal coupler.The coil was removed together with the microcatheter.The procedure was completed with another embold? coil of the same size.There were no patient complications as a result of this event.It was further reported that two microcatheters were used in this case, but it could not be confirmed which one encountered the issue: a 2.4f non-boston scientific microcatheter and a truselect microcatheter.

• 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: 22893615
• Report Number: 2124215-2025-59689
• Device Sequence Number: 14910064
• Product Code: KRD
• UDI-Device Identifier: 00191506026615
• UDI-Public: (01)00191506026615(17)280421(10)36343961
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 10/31/2025

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: M001394260000600
• Device Catalogue Number: M001394260000600
• Device Lot Number: 0036343961
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/31/2025
• Date Device Manufactured: 04/22/2025
• 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: Unknown