MAUDE Adverse Event Report: Medos International SARL DELTAXSFT; Device, Vascular, for Promoting Embolization

Catalog Number	DLX100153
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction

• Brand Name: DELTAXSFT
• Common Device Name: Device, Vascular, for Promoting Embolization
• Manufacturer (Section D): Medos International SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): Cerenovus, Inc. (Fremont); 47709 fremont blvd.; fremont CA 94538
• Manufacturer Contact: katie seppa ; 31 technology dr.; irvine, CA 92618 ; +1(513)337-8052
• MDR Report Key: 50809177
• Report Number: 3008114965-2026-01244
• Device Sequence Number: 8597191
• Product Code: KRD
• UDI-Device Identifier: 10886704077268
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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 Catalogue Number: DLX100153
• Device Lot Number: 2232564S
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2025
• 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