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

Model Number	M001394240030060
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pusher wire fractured and additional intervention was required.An embold fibered 3x6 was selected for use in a pelvic embolization procedure.The coil was advanced to the target lesion and the proximal release perforation was broken to deploy the coil.At this point, the physician noticed radio opaque markers in the distal segment of catheter and saw that the coil pusher wire had broken off and was still attached to coil.The physician pulled the entire microcatheter system and inserted a microsnare to snare the coil and pusher wire fragment.The device fragment and the coil were successfully snared in the unknown 5 fr catheter and the entire system was removed from the patient.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the returned device consisted of an embold fibered coil without the delivery system.The coil was attached to a microcatheter and snare.The device was examined microscopically to reveal a stretched coil and bent distal coupler.The reported event was confirmed.Device history record (dhr) review: a ship history review for the reported upn was performed for the reporting customer.Batches 37639170, 37106625, and 37106624 were most recently shipped to the reporting facility in the 3-year period preceding the procedure date.There were no manufacturing deviations for any of the three batch numbers that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review performed for the embold device confirmed that the reported events are known events defined in the product's risk management documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause linked to device but unable to trace more specifically.
Event or Problem Description
It was reported that the pusher wire fractured and additional intervention was required.An embold fibered 3x6 was selected for use in a pelvic embolization procedure.The coil was advanced to the target lesion and the proximal release perforation was broken to deploy the coil.At this point, the physician noticed radio opaque markers in the distal segment of catheter, and saw that the coil pusher wire had broken off and was still attached to coil.The physician pulled the entire microcatheter system and inserted a microsnare to snare the coil and pusher wire fragment.The device fragment and the coil were successfully snared in the unknown 5 fr catheter and the entire system was removed from the patient.There were no patient complications as a result of this event.

• 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 24313841
• Report Number: 2124215-2026-07682
• Device Sequence Number: 12158513
• Product Code: KRD
• UDI-Device Identifier: 08714729983545
• UDI-Public: (01)08714729983545(17)280730(10)37106624
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/09/2026

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 Model Number: M001394240030060
• Device Catalogue Number: M001394240030060
• Device Lot Number: 0037106624
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 04/09/2026
• Date Device Manufactured: 07/31/2025
• 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