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

Model Number	M001394240020040
Medical Device Problem Codes	Stretched (1601); Difficult to Advance (2920); Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil was stretched and protruding from the target vessel, requiring intervention.This 2x4 embold fibered was selected for use in a hypogastric bleed procedure.A non-boston scientific microcatheter was placed in the mildly tortuous target vessel.The embold coil was inserted into the vessel and was believed to have been deployed.Then the pull wire was retracted outside of the microcatheter.A second coil was inserted into the microcatheter; however, was unable to track past the tip of the microcatheter.Angiography was performed which revealed the first coil was stretched and hanging outside of the target vessel.A snare was used to remove the entire coil.Access was gained to the vessel again and a different device was used to complete the procedure.It was also noted that the coil was difficult to deploy as the couplers were not visible once the coil was removed.There were no patient complications.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, microscopic inspection of this embold coil revealed a stretched coil 2cm from the distal tip, and detachment from the coupler.Product analysis confirmed the reported event of the coil stretched.
Event or Problem Description
It was reported that the coil was stretched and protruding from the target vessel, requiring intervention.This 2x4 embold fibered was selected for use in a hypogastric bleed procedure.A non-boston scientific microcatheter was placed in the mildly tortuous target vessel.The embold coil was inserted into the vessel and was believed to have been deployed.Then the pull wire was retracted outside of the microcatheter.A second coil was inserted into the microcatheter; however, was unable to track past the tip of the microcatheter.Angiography was performed which revealed the first coil was stretched and hanging outside of the target vessel.A snare was used to remove the entire coil.Access was gained to the vessel again and a different device was used to complete the procedure.It was also noted that the coil was difficult to deploy as the couplers were not visible once the coil was removed.There were no patient complications.

• Brand Name: EMBOLD FIBERED
• 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: 21149377
• Report Number: 2124215-2025-00514
• Device Sequence Number: 15736870
• Product Code: KRD
• UDI-Device Identifier: 08714729983521
• UDI-Public: 08714729983521
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K213398
• 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): 02/04/2025

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: M001394240020040
• Device Catalogue Number: M001394240020040
• Device Lot Number: 0034758440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2024
• 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