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

Model Number	M001394240040080
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the returned embold fibered was inserted in the delivery sheath backwards with the perforations intact.Microscopic inspection revealed the coil was separated from the coupler while the coil coupler is still attached to the delivery wire.The delivery wire distal tip has multiple kinks and the couplers are bent.
Event or Problem Description
Reportable based on device analysis completed on 24feb2025.It was reported that difficulty advancing occurred.A 4x8 embold fibered was selected for an embolization procedure to treat a pancreatic aneurysm.The 4x8 coil was advanced; however, the physician decided on using a smaller coil first.The 4x8 coil was removed from the patient and re-housed in the loop in saline.The coil was pulled out of the hoop for later use, but it would not advance through the microcatheter.A total of 17 embold coils were used in the procedure.There were no patient complications as a result of this event.However, device analysis revealed coil detachment.

• 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: 21677853
• Report Number: 2124215-2025-17836
• Device Sequence Number: 20768402
• Product Code: KRD
• UDI-Device Identifier: 08714729983569
• UDI-Public: 08714729983569
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 03/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M001394240040080
• Device Catalogue Number: M001394240040080
• Device Lot Number: 0034350722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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
• Patient Sex: Unknown