MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBOLD? Fibered; Device, Vascular, For Promoting Embolization

Model Number	M001394240100500
Medical Device Problem Codes	Stretched (1601); Device-Device Incompatibility (2919); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil stretched out of the target location.A 10mm x 50cm embold? fibered coil was selected for use in an embolization procedure of the non-tortuous left ovarian vein.The target vessel diameter was 6-7 mm.The patient was being treated for pelvic congestion.The distal left ovarian vein was embolized with two embold? fibered coils successfully.Afterwards, the proximal ovarian vein was embolized with two embold? fibered coils.It appeared normal and the whole delivery system and microcatheter were pulled out of the ovarian vein; however, in doing so, the second to last coil became entangled with either the microcatheter or the 5fr catheter, resulting in the coil unraveling with a strand stretched out.A fine strand of the coil extended all the way back into the sheath through the inferior vena cava (ivc).During removal of the microcatheter, tension on this strand pulled the proximal portion of the coil up into the renal vein.The team was able to reposition the proximal portion of the coil back into the ovarian vein; however, despite several hours of effort, using various guidewires and snares, they were unable to retrieve the remaining strand that extended out into the renal vein nor were they able to push it back into the ovarian vein.The coil never broke, but the stretched strand was cut down at the groin access.The surgeon decided to leave the remainder of the stretched coil in place due to its very small size.The procedure was prolonged as a result of this event.The patient was put on aspirin for the next three months with an expectation to recover fully.

• 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 ; +1(952)930-6396
• MDR Report Key: 50116340
• Report Number: 2124215-2026-41459
• Device Sequence Number: 5306110
• Product Code: KRD
• UDI-Device Identifier: 08714729983651
• UDI-Public: (01)08714729983651(17)310321(10)38896427
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K213398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2026

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: M001394240100500
• Device Catalogue Number: M001394240100500
• Device Lot Number: 0038896427
• 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: 07/06/2026
• Supplement Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 03/22/2026
• 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 Age: 48 YR
• Patient Sex: Female