MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VortX? Diamond - 18; device, vascular, for promoting embolization

Model Number	M0013822050
Medical Device Problem Codes	Failure to Advance (2524); Malposition of Device (2616)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction

• Brand Name: VortX? Diamond - 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 50946993
• Report Number: 2124215-2026-51973
• Device Sequence Number: 21207084
• Product Code: KRD
• UDI-Device Identifier: 08714729324898
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K102714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: M0013822050
• Device Catalogue Number: M0013822050
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/30/2026
• 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