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

Model Number	M001394250040300
Medical Device Problem Codes	Premature Activation (1484); Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil stretched and prematurely deployed, which required intervention.A 4mm x 30cm embold soft coil was selected for use in an embolization procedure of the moderately tortuous superior mesenteric artery.During the procedure, while attempting to deploy the coil into the coil pack, there was resistance, and attempts were made to pull and push the coil to release tension in the delivery wire.It was thought that the coil could have been caught in the coil pack.An attempt was made to pull back on the microcatheter; however, it was observed that the coil had stretched out, and the coil ended up deploying inside the microcatheter.The coil had to be snared out.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device eval by manufacturer: the device was not returned for analysis; however, media was received, which was thoroughly examined and evaluated.It revealed a stretched coil removed with a snare.
Event or Problem Description
It was reported that the coil stretched and prematurely deployed, which required intervention.A 4mm x 30cm embold soft coil was selected for use in an embolization procedure of the moderately tortuous superior mesenteric artery.During the procedure, while attempting to deploy the coil into the coil pack, there was resistance, and attempts were made to pull and push the coil to release tension in the delivery wire.It was thought that the coil could have been caught in the coil pack.An attempt was made to pull back on the microcatheter; however, it was observed that the coil had stretched out, and the coil ended up deploying inside the microcatheter.The coil had to be snared out.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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22285472
• Report Number: 2124215-2025-40243
• Device Sequence Number: 15570240
• Product Code: KRD
• UDI-Device Identifier: 00191506026479
• UDI-Public: (01)00191506026479(17)270701(10)34349076
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/24/2025

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: M001394250040300
• Device Catalogue Number: M001394250040300
• Device Lot Number: 0034349076
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/24/2025
• Date Device Manufactured: 07/01/2024
• 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