MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF181040
Medical Device Problem Codes	Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section d2b ¿ procode: krd/hcg an analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device 0282601s number, and no internal actions related to the malfunction were identified.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.The instructions for use (ifu) caution that if unusual friction is still noticed during advancement or retraction of the coil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire catheter system and examine for damage.Replace it with a new system.If friction still exists, withdraw and examine the delivery catheter system.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
A healthcare professional reported that this was an endovascular embolization of a splenic artery aneurysm, the embolization of splenic artery aneurysm was performed using a 4fr angiographic catheter and lighthouse microcatheter (mc).After framing with a target xxl (stryker), the user initiated filling using dlf coils.After using one 18mm and one 12mm coil, the user attempted to place a deltafill18 10mm x 40cm (product code: dlf181040, lot number: 0282601s).The physician noted stiffness when placing the coil compared with usual.Considering the possibility that the microcatheter position was not proper, re-sheathed the coil and adjusted the microcatheter position twice.While advancing and re-sheathing the coil thereafter, it unraveled.The deltafill coil was retrieved with the microcatheter and the whole system was changed.The procedure was completed using a competitor¿s coil.There was no negative impact to the patient.A continuous flush was done.The devices were used according to the instructions for use (ifu).
Additional Manufacturer Narrative
Manufacturer ref#(b)(4).Updated sections on this medwatch: b4, b5, g3, g6, h2, and h11.Section b5: additional event information received on 18-may-2026 indicated that a lighthouse microcatheter was used.The microcatheter did not kick back.Prior to this coil, target xxl coils were able to be advanced through the same microcatheter.There was no blood flow restriction/reduction as a result of the event.The unraveled coil was retrieved with the microcatheter (mc).There was no allegation of patient injury due to an alleged product issue.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: DELTAFILL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 25149806
• Report Number: 3008114965-2026-00672
• Device Sequence Number: 9212758
• Product Code: KRD
• UDI-Device Identifier: 10886704077114
• UDI-Public: (01)10886704077114(17)290131(10)0282601S
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2026

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: DLF181040
• Device Lot Number: 0282601S
• 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: 04/23/2026
• Supplement Date Received by Manufacturer: 05/19/2026; 06/04/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 05/19/2026; 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2026
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian