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

Model Number	M001394260000600
Medical Device Problem Codes	Premature Activation (1484); Stretched (1601); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil stretched and protruded from the target lesion, and needed to be snared from the vasculature.An embold packing was selected for use in the renal embolization procedure.The coil was advanced to the target lesion without resistance.When the coil was retracted, the coil stretched and deployed prematurely, protruding from the target vessel into the aorta.A snare was used to remove the coil from the patient.An additional embold coil was used to complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
Device evaluation: the returned device consists of embold packing coil in 2 pieces.The device was examined visually to reveal packing coil broke and stretched in a snare.The delivery system was not returned.Another piece of the coil was stretched wrapped around the returned non-bsc microcatheter.The stretched coil was removed from the microcatheter.Media submitted with the complaint has been thoroughly examined and evaluated to reveal a stretched coil and coil protruding from target site.
Event or Problem Description
It was reported that the coil stretched and protruded from the target lesion, and needed to be snared from the vasculature.An embold? packing was selected for use in the renal embolization procedure.The coil was advanced to the target lesion without resistance.When the coil was retracted, the coil stretched and deployed, protruding from the target vessel into the aorta.A snare was used to remove the coil from the patient.An additional embold coil was used to complete the procedure.There were no patient complications.

• 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: 22310505
• Report Number: 2124215-2025-41129
• Device Sequence Number: 8082297
• Product Code: KRD
• UDI-Device Identifier: 00191506026615
• UDI-Public: (01)00191506026615(17)270822(10)34692122
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 07/29/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M001394260000600
• Device Catalogue Number: M001394260000600
• Device Lot Number: 0034692122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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