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

Model Number	M001394250060300
Medical Device Problem Codes	Break (1069); Premature Activation (1484); Malposition of Device (2616); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Detailed product information was not provided to bsc and was unavailable per the customer.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.Investigation results: device analysis findings: the device was implanted; therefore, a technical analysis was unable to be performed.Device history record (dhr) review: a ship history review for the reported upn was performed for the reporting customer.Of the batches most recently shipped to the reporting facility preceding the procedure date, there were no manufacturing deviations for any of the batch numbers 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 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 unable to exclude device problem.
Event or Problem Description
It was reported that the coil prematurely deployed, and protruded from the target lesion.An embold soft 6x30 was selected for use to treat a gastrointestinal bleed.The target lesion was located in the mildly tortuous and calcified gastroduodenal artery (gda), which was 6 mm in diameter.During use of the embold soft 6x30, the coil deployed prematurely within the microcatheter without breaking the proximal release perforation.As a result, the physician was unable to position the coil precisely within the target lesion.The physician was able to push the coil out of the microcatheter, but a portion of the coil extended from the gda into the hepatic artery.There was no additional intervention performed, and no patient complications as a result of this event.The patient was expected to recover fully.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc, and was unavailable per the customer.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.Investigation results: device analysis findings: the device was implanted; therefore, a technical analysis was unable to be performed.Device history record (dhr) review: a ship history review for the reported upn was performed for the reporting customer.Of the batches most recently shipped to the reporting facility preceding the procedure date, there were no manufacturing deviations for any of the batch numbers 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 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 unable to exclude device problem.
Event or Problem Description
It was reported that the coil prematurely deployed, and protruded from the target lesion.An embold soft 6x30 was selected for use to treat a gastrointestinal bleed.The target lesion was located in the mildly tortuous and calcified gastroduodenal artery (gda), which was 6 mm in diameter.During use of the embold soft 6x30, the coil deployed prematurely within the microcatheter without breaking the proximal release perforation.As a result, the physician was unable to position the coil precisely within the target lesion.The physician was able to push the coil out of the microcatheter, but a portion of the coil extended from the gda into the hepatic artery.There was no additional intervention performed, and no patient complications as a result of this event.The patient was expected to recover fully.It was further clarified that the coil broke within the microcatheter at the coupler.

• 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 LIMITED; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 24606925
• Report Number: 2124215-2026-14376
• Device Sequence Number: 16045432
• Product Code: KRD
• UDI-Device Identifier: 00191506026547
• UDI-Public: (01)00191506026547
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K230706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 04/27/2026

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: M001394250060300
• Device Catalogue Number: M001394250060300
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/27/2026
• 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
• Patient Sex: Unknown