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

Model Number	M001394260000450
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil broke and was difficult to remove, requiring an additional device.This embold packing 45 was selected for use during an epigastric embolization procedure in mildly tortuous anatomy.During the procedure when this embold packing coil was being advanced, the pusher wire detached, and the internal wire stayed attached to the couplers.An attempt was made to remove the entire system; however, only the delivery wire came out with both couplers remaining on the delivery wire.A snare was used to pull out the coil which experienced stretching and breaking in several areas.Three different snares were used to extract the coil, and the procedure was completed using pushable coils.There were no 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 device was returned with two non-boston scientific guide catheters and three snares holding pieces of the coil.The device was examined visually and microscopically which revealed the perforations were not broken.The coil stretched and wrapped around the three snares while the coil broke from the coupler.Photographs were submitted which were thoroughly examined and evaluated to reveal an x-ray image of the stretched coil in the patient.The reported event was confirmed.
Event or Problem Description
It was reported that the coil broke and was difficult to remove, requiring an additional device.This embold packing 45 was selected for use during an epigastric embolization procedure in mildly tortuous anatomy.During the procedure when this embold packing coil was being advanced, the pusher wire detached, and the internal wire stayed attached to the couplers.An attempt was made to remove the entire system; however, only the delivery wire came out with both couplers remaining on the delivery wire.A snare was used to pull out the coil which experienced stretching and breaking in several areas.Three different snares were used to extract the coil, and the procedure was completed using pushable coils.There were no patient complications as a result of this event.It was further reported that this did not occur during an attempt to deploy the coils, as the proximal release perforation was not broken.There was a detachment at the couplers.

• 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: 22155100
• Report Number: 2124215-2025-30685
• Device Sequence Number: 7273597
• Product Code: KRD
• UDI-Device Identifier: 00191506026608
• UDI-Public: (01)00191506026608(17)271111(10)35254656
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/25/2025

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: M001394260000450
• Device Catalogue Number: M001394260000450
• Device Lot Number: 0035254656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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