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); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil broke, and snaring was required to retrieve it.A 60cm embold packing coil was selected for use in the embolization of a pseudoaneurysm off of the gastroduodenal artery (gda) and accessory vessels with low tortuosity.Intermittent flushing was performed.The first 60cm embold packing coil was deployed successfully.This second 60cm embold packing coil was advanced without resistance and started to coil in the vessel.However, the middle portion of the coil would not pack tightly enough into the vessel.It was repositioned five or six times to try for a better pack, but then it stretched out.After the coil stretched, a snare was used to grab the coil, but while attempting to retract the coil, it broke.The coil broke at the stretched portion, and a portion of the coil was left hanging out of the parent vessel.This portion of the coil was snared and broke a few times and then snared again.The portion of the coil that was outside of the parent vessel was snared out, and the portion inside the target vessel was left where it was.Two new embold coils were used to finish embolizing the target vessel.The target vessel was embolized without problem.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device eval by manufacturer: the returned device consisted of the embold packing device without the delivery sheath and the perforations intact.The coil arrived broken in two parts.The device was examined visually and microscopically to reveal a stretched coil separated from the coupler.A kink to the polymer shaft was observed approximately 5.5cm from the coupler.There was coupler damage, but the couplers remained connected.
Event or Problem Description
It was reported that the coil broke, and snaring was required to retrieve it.A 60cm embold packing coil was selected for use in the embolization of a pseudoaneurysm off of the gastroduodenal artery (gda) and accessory vessels with low tortuosity.Intermittent flushing was performed.The first 60cm embold packing coil was deployed successfully.This second 60cm embold packing coil was advanced without resistance and started to coil in the vessel.However, the middle portion of the coil would not pack tightly enough into the vessel.It was repositioned five or six times to try for a better pack, but then it stretched out.After the coil stretched, a snare was used to grab the coil, but while attempting to retract the coil, it broke.The coil broke at the stretched portion, and a portion of the coil was left hanging out of the parent vessel.This portion of the coil was snared and broke a few times and then snared again.The portion of the coil that was outside of the parent vessel was snared out, and the portion inside the target vessel was left where it was.Two new embold coils were used to finish embolizing the target vessel.The target vessel was embolized without problem.There were no patient complications as a result of this event.

• 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: 21791845
• Report Number: 2124215-2025-20964
• Device Sequence Number: 7868105
• Product Code: KRD
• UDI-Device Identifier: 00191506026615
• UDI-Public: (01)00191506026615(17)271024(10)35137167
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K230706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 05/12/2025

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: 0035137167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Race: White