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

Model Number	M001394250020040
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil migrated post-deployment.An embold soft 2x4 coil was selected for use during a gastrointestinal (gi) bleed procedure.The vessel was mildly tortuous, and the coil fully deployed without any issues.While attempting to access another branch using a.014 non-boston scientific wire, the wire inadvertently entered the wrong branch and hooked the deployed coil, resulting in coil dislodgement.The entire system, including the microcatheter and base catheter, was withdrawn and flushed; however, the coil could not initially be located.Upon reinsertion of the base catheter, the coil was visualized under fluoroscopy protruding from the side hole of the base catheter and was successfully retrieved.Prior to this issue, other embold coils had been successfully implanted; therefore, the procedure was complete.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device analysis findings: upon receipt at our post market quality assurance laboratory, this embold soft coil was received without the delivery system.The device was examined microscopically to reveal a stretched coil.The reported event was confirmed.Device history record (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a review of the embold soft device was completed and confirmed that the event of migration was defined in the risk documentation.This event type has 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, due to the reported information does not clearly indicate a cause of the reported issue.
Event or Problem Description
It was reported that the coil migrated post-deployment.An embold soft 2 x 4 coil was selected for use during a gastrointestinal (gi) bleed procedure.The vessel was mildly tortuous, and the coil fully deployed without any issues.While attempting to access another branch using a.014 non-boston scientific wire, the wire inadvertently entered the wrong branch and hooked the deployed coil, resulting in coil dislodgement.The entire system, including the microcatheter and base catheter, was withdrawn and flushed; however, the coil could not initially be located.Upon reinsertion of the base catheter, the coil was visualized under fluoroscopy protruding from the side hole of the base catheter and was successfully retrieved.Prior to this issue, other embold coils had been successfully implanted; therefore, the procedure was complete.There were no patient complications as a result of this event.

• Brand Name: EMBOLD? SOFT
• 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: 24151051
• Report Number: 2124215-2026-04129
• Device Sequence Number: 9487307
• Product Code: KRD
• UDI-Device Identifier: 00191506026370
• UDI-Public: (01)00191506026370(17)280710(10)36947011
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K230706
• 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): 03/23/2026

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: M001394250020040
• Device Catalogue Number: M001394250020040
• Device Lot Number: 0036947011
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2025
• 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
• Patient Sex: Unknown