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); Stretched (1601); Difficult to Advance (2920); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil was protruding outside the target location, requiring intervention.This embold packing coil was selected for use during a splenic artery embolization procedure.The target vessel had moderate tortuosity.During the procedure, the embold packing coil was difficult to advance.The coil was then deployed, and the physician attempted to retrieve the coil in order to reposition it; however, increased resistance was felt upon retrieval.The coil became stretched and broken as a result.The pusher wire was removed leaving the coil outside the target vessel.A second coil was successfully placed.The procedure was prolonged.The patient was stable post procedure, and an additional surgery was scheduled to remove the coil.There were no other patient complications as a result of this event.
Event or Problem Description
It was reported that the coil was protruding outside the target location, requiring intervention.This embold? packing coil was selected for use during a splenic artery embolization procedure.The target vessel had moderate tortuosity.During the procedure, the embold packing coil was difficult to advance.The coil was then deployed, and the physician attempted to retrieve the coil in order to reposition it; however, increased resistance was felt upon retrieval.The coil became stretched and broken as a result.The pusher wire was removed leaving the coil outside the target vessel.The procedure was prolonged, and an additional surgery was performed to remove the coil.There were no other patient complications as a result of this event.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this embold packing device was visually examined, which revealed a stretched coil and bent couplers.X-ray was used to show the broken coil line stuck inside the sheath.Inspection of the remainder of the device presented no other damage or irregularities.It was found that the break and stretching was likely due to when attempting to retrieve the device.

• 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: 23183217
• Report Number: 2124215-2025-65611
• Device Sequence Number: 13048154
• Product Code: KRD
• UDI-Device Identifier: 00191506026615
• UDI-Public: (01)00191506026615(17)280622(10)36812917
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 11/06/2025

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: 0036812917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• 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
• Patient Age: 37 YR
• Patient Sex: Female