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

Model Number	M001394240140300
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601); Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920); Material Deformation (2976); 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	01/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G1: mfr site zip/post code: t12 yk88.Device evaluated by mfr: the returned device consists of an embold fibered delivery system with the perforations intact.The device was returned with a non-boston scientific (bsc) guide catheter, non-bsc microcatheter, and a non-bsc snare.Microscopic examination revealed bent couplers, stretched coil, and the coil detached from the coupler.The coil was tangled in the snare.The reported event was confirmed.
Event or Problem Description
It was reported that the coil broke requiring additional intervention.A 14x30 embold fibered was selected for use in a renal artery aneurysm embolization procedure.The vessel was mildly tortuous.After the initial angiogram, it was determined the aneurysm was approximately 14mm in diameter.After introducing the coil into the vessel, difficulty occurred while forming the coil.After several repositioning attempts, the distal portion of the coil appeared to fall out of the aneurysm and track back toward the parent vessel.A knot formed in the middle of the coil during retraction of the coil into the 2.8 non-boston scientific microcatheter.An attempt to remove the entire system was made; however, the knot was too large and became lodged in the vessel.It was then determined that the aneurysm was also associated with a venous fistula, and the initial coil deployment had occurred in a 4mm venous vessel, explaining why the coil was not forming properly.At this point, the left femoral vein was accessed in an attempt to remove the coil from the venous side.After snaring the coil and pulling, the physician felt significant resistance.The coil stretched and broke from the couplers while pulling from the arterial side.A hemostat was clamped onto the diagnostic catheter to hold the proximal coil.Pulling simultaneously from both the snare and the diagnostic catheter caused the coil to snap.The knot was removed from the venous side, and the stretched part of the coil was removed through the arterial sheath.An angiogram was then performed, a new microcatheter was introduced, and the aneurysm was embolized starting with a 10x30 embold fibered coil.Both sheaths were removed, and the patient was sent to postoperative recovery with no further issues.

• 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: 24431747
• Report Number: 2124215-2026-10181
• Device Sequence Number: 10304404
• Product Code: KRD
• UDI-Device Identifier: 08714729983705
• UDI-Public: (01)08714729983705(17)260312(10)31223113
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 02/24/2026

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 Expiration Date: 03/12/2026
• Device Model Number: M001394240140300
• Device Catalogue Number: M001394240140300
• Device Lot Number: 0031223113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: 2.8 PROGREAT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown