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

Model Number	M001394250080600
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316); Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip broke.An 8mm x 60 cm embold soft coil was selected for use in a splenic embolization procedure.During the procedure, the tip broke due to difficulty re-capturing into the introducer sheath.The device was exchanged for another one, and the procedure was successfully completed.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that the tip broke.An 8mm x 60 cm embold soft coil was selected for use in a splenic embolization procedure.During the procedure, the tip broke due to difficulty re-capturing into the introducer sheath.The device was exchanged for another one, and the procedure was successfully completed.There were no patient complications as a result of this event.It was further reported that the tip of the coil did not break.Instead, the issue was difficulty inserting into the hub of the microcatheter due to a curled tip as well as difficulty re-sheathing the coil into the introducer sheath.This event occurred outside the body, and the device was not used inside the patient.
Additional Manufacturer Narrative
Device eval by manufacturer: the device was returned for analysis with the embold delivery wire reinserted backwards in the delivery sheath.The perforations remained intact.Microscopic examination revealed a stretched coil while in the delivery sheath.Couplers were bent but held together by the delivery wire with the coil still connected.
Event or Problem Description
It was reported that the tip broke.An 8mm x 60 cm embold soft coil was selected for use in a splenic embolization procedure.During the procedure, the tip broke due to difficulty re-capturing into the introducer sheath.The device was exchanged for another one, and the procedure was successfully completed.There were no patient complications as a result of this event.It was further reported that the tip of the coil did not break.Instead, the issue was difficulty inserting into the hub of the microcatheter due to a curled tip as well as difficulty re-sheathing the coil into the introducer sheath.This event occurred outside the body, and the device was not used inside the patient.

• 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: 21922542
• Report Number: 2124215-2025-26365
• Device Sequence Number: 15711206
• Product Code: KRD
• UDI-Device Identifier: 00191506026578
• UDI-Public: (01)00191506026578(17)270502(10)33949109
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2025

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: M001394250080600
• Device Catalogue Number: M001394250080600
• Device Lot Number: 0033949109
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 05/08/2025; 06/06/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 06/04/2025; 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown