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

Model Number	M001394240020040
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information was not provided to boston scientific.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the lot # is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the coil stretched and broke, and snaring was required to remove the device.A 2mm x 4cm embold? fibered coil was selected for use in an embolization procedure to treat a bleed.During the procedure, the coil stretched and unraveled.After the coil stretched, it could not be advanced or retracted.The coil was able to be snared from the patient's body.The device broke inside the patient and was removed in multiple pieces.The procedure was completed using an alternate device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
B3: date of event: there was additional information that this case could have taken place in 2023, and we completed a good faith effort to clarify, but the information could not be confirmed.D4: model number, catalog number, and unique identifier (udi): there was additional information that the size of the embold? fibered coil could have been 14mm x 50cm.We completed a good faith effort to clarify, but the information could not be confirmed.A 14mm x 50cm embold? fibered coil corresponds to model number/catalog number: m001394240140500 and incomplete udi: (b)(4).Detailed product information was not provided to boston scientific.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the lot # is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the coil stretched and broke, and snaring was required to remove the device.A 2mm x 4cm embold? fibered coil was selected for use in an embolization procedure to treat a bleed.During the procedure, the coil stretched and unraveled.After the coil stretched, it could not be advanced or retracted.The coil was able to be snared from the patient's body.The device broke inside the patient and was removed in multiple pieces.The procedure was completed using an alternate device.There were no patient complications as a result of this event.It was further reported that the patient was being treated for a large hepatic pseudoaneurysm.Numerous embold? coils were used.This was the final coil used in the procedure.There is a possibility that the embold? fibered coil was actually a 14mm x 50cm; however, this information could not be confirmed.

• 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: 22953030
• Report Number: 2124215-2025-61532
• Device Sequence Number: 18608740
• Product Code: KRD
• UDI-Device Identifier: 08714729983521
• UDI-Public: (01)08714729983521
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 11/19/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 11/19/2025
• 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