MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VORTX? - 18; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	M0013812060
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2026.It was reported that the main coil could not be advanced through the catheter.The target lesion was located in a venous embolism associated with pelvic congestion syndrome.A bsc stc18 microcatheter was advanced to the intended release position, and a vortx-18 6 mm x 6.5 mm coil was selected for use.The coil initially advanced without issue but encountered resistance in the distal portion of the microcatheter.Multiple attempts were made to advance the coil, including saline flushing and guidewire assistance, but none were successful.Upon withdrawal of the microcatheter, it was noted that the coil had already formed and become lodged within the microcatheter lumen.The guidewire was re-used in an attempt to deploy the coil.The guidewire was advanced into the mid-portion of the coil, and the angiography catheter was then used to deliver a foam sclerosing agent.Follow-up angiography performed after 5 minutes demonstrated slowed flow with no visualization of the distal portion of the microcatheter.The coil was not implanted, and the procedure was completed.There were no reported patient complications associated with this event.However, device analysis revealed that the zap tip of the coil was detached.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Investigation results: device/media analysis: upon receipt at our post market quality assurance laboratory, it was observed that the main coil was bent and stretched at the primary coil section; moreover, a zap tip was detached.No other issues were identified during the product analysis.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.Conclusion: based on a thorough review of the reported complaint, boston scientific concludes the most probable root cause as adverse event related to procedure.

• Brand Name: VORTX? - 18
• 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: 25322680
• Report Number: 2124215-2026-28740
• Device Sequence Number: 5280456
• Product Code: KRD
• UDI-Device Identifier: 08714729201199
• UDI-Public: (01)08714729201199(17)260613(10)31816192
• 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
• Report Date (Section B): 05/28/2026

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 Expiration Date: 06/13/2026
• Device Model Number: M0013812060
• Device Catalogue Number: M0013812060
• Device Lot Number: 0031816192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2023
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 63 KG