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

Catalog Number	DLF180835
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).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 2232558s 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.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 upon opening the package of deltafill18 coil (product code: dlf180835, lot number 2232558s) the delivery wire and sheath were found to be torn, rendering the device unusable.The device was discarded.There was no visible damage to the outer box or other packaging.The deltafill18 was replaced with another new device of the same specification, which was successfully implanted.Patient impact: no adverse events or negative clinical impact were reported.
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 07-apr-2026 indicated that the device was stored and handled according to the instructions for use (ifu).There was no visible damage noted to the packaging.The integrity of the sterile pouch was not compromised.The procedure was completed by using another deltafill18 8mm x 35cm.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: 24790672
• Report Number: 3008114965-2026-00500
• Device Sequence Number: 9727615
• Product Code: KRD
• UDI-Device Identifier: 10886704077220
• UDI-Public: (01)10886704077220(17)280731(10)2232558S
• 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
• Report Date (Section B): 04/08/2026

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: DLF180835
• Device Lot Number: 2232558S
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2025
• 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