MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMPLEX HELICAL - 18; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0013120770
Medical Device Problem Codes	Failure to Advance (2524); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6) reported here as phone number exceeded character limit for designated field.
Event or Problem Description
It was reported that the coil could not be deployed requiring additional intervention.The patient was presented with bleeding stomach.The target lesion was severely tortuous.Two 11mm/17mm complex helical - 18 coil were selected for use.During the procedure, when approaching the area of the lesion, the tail end got stuck and the coil could not be deployed inside the body, the coil stays in the patient after the catheter was removed, and the snare was used to remove from the patient.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Reported here as phone number exceeded character limit for designated field.
Event or Problem Description
It was reported that the coil could not be deployed requiring additional intervention.The patient was presented with bleeding stomach.The target lesion was severely tortuous.Two 11mm/17mm complex helical, 18 coils were selected for use.During the procedure, when approaching the area of the lesion, the tail end got stuck and the coil could not be deployed inside the body, the coil stays in the patient after the catheter was removed, and the snare was used to remove from the patient.The procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that the failure appears the same way in both coil deployments and both coils were needed to be snared to be able to be removed from the patient, the procedure was completed with coils and glue.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6) reported here as phone number exceeded character limit for designated field.Device evaluated by mfr: the device was returned for evaluation.Visual and microscope inspections were performed.It was observed that the main coil and coil introducer were returned.It was observed that the main coil was bent and stretched at the primary coil section.Dimensional inspection of the main coil revealed the components were within specification.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the coil could not be deployed requiring additional intervention.The patient was presented with bleeding stomach.The target lesion was severely tortuous.Two 11mm/17mm complex helical - 18 coil were selected for use.During the procedure, when approaching the area of the lesion, the tail end got stuck and the coil could not be deployed inside the body, the coil stays in the patient after the catheter was removed, and the snare was used to remove from the patient.The procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that the failure appears the same way in both coil deployments and both coils were needed to be snared to be able to be removed from the patient, the procedure was completed with coils and glue.

• Brand Name: COMPLEX HELICAL - 18
• Common Device Name: DEVICE, NEUROVASCULAR 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: 22916283
• Report Number: 2124215-2025-59663
• Device Sequence Number: 13200302
• Product Code: KRD
• UDI-Device Identifier: 08714729324096
• UDI-Public: (01)08714729324096(17)270129(10)33533043
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K102714
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2025

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: M0013120770
• Device Catalogue Number: M0013120770
• Device Lot Number: 0033533043
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 09/11/2025; 10/21/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 10/08/2025; 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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