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

Model Number	M001394260000300
Medical Device Problem Codes	Break (1069); Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information was not provided to boston scientific.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.
Event or Problem Description
It was reported that the coil broke requiring additional intervention.An embold packing coil was selected for use in a celiac bleed embolization procedure.During placement of the coil into the 3-4mm vessel, resistance was felt.The coil was pulled back; however, the coil stretched and snapped in the vessel.A snare was used to remove some of the coil.The patient was hospitalized beyond standard of care, and another case was scheduled to retrieve/snare the remaining portion of the coil from the aorta.The issue is ongoing.
Event or Problem Description
It was reported that the coil broke requiring additional intervention.An embold packing coil was selected for use in a celiac bleed embolization procedure.During placement of the coil into the 3-4mm vessel, resistance was felt.The coil was pulled back; however, the coil stretched and snapped in the vessel.A snare was used to remove some of the coil.The patient was hospitalized beyond standard of care, and another case was scheduled to retrieve/snare the remaining portion of the coil from the aorta.The issue is ongoing.
Additional Manufacturer Narrative
Mfr evaluation: the complaint device was not received for analysis.The media submitted with the complaint has been thoroughly examined and evaluated to reveal an x-ray image of what appears to be a microcatheter near a spinal column with a coil a few centimeters away from the tip.The image does not confirm a damaged device.Detailed product information was not provided to boston scientific.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.

• 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: 23709694
• Report Number: 2124215-2025-88298
• Device Sequence Number: 10649644
• Product Code: KRD
• UDI-Device Identifier: 00191506026592
• UDI-Public: (01)00191506026592
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/18/2025

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: M001394260000300
• Device Catalogue Number: M001394260000300
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/18/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown