MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CEREPAK FREEFORM; CEREPAK FREEFORM MINI DETACHABLE COIL SYSTEM

Catalog Number	MCR091540
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was found damaged and stretched, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section d2b: procode: krd/hcg.The device was returned to j&j medtech for further evaluation.A non-sterile freeform mini 1.5mm x 4cm coil was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the delivery system was inside the introducer.The embolic coil was slightly protruding from the introducer's tip.The manual break was not attempted.The embolic coil was attempted to be advanced through the introducer sheath; however, high resistance was met.An inspection under x-ray imaging revealed that the proximal end of the embolic coil was highly stretched and folded inside the introducer.A manufacturing record evaluation was performed for the finished device 31585344 number, and no non-conformance's related to the malfunction were identified.The issue reported regarding the embolic coil being impeded in the introducer sheath is confirmed.The damages on the embolic coil suggest that a sufficient saline flush was not maintained since according to risk documentation, when an adequate continuous saline flush is not maintained, friction between microcoil system and microcatheter may become a potential effect of failure.An increase of friction can lead to device damage such as stretching.There is no indication that the issues reported in the complaint result from a defect inherently related to the device.As part of j&j medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at final assembly to prevent damage from leaving the facility.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) state the following: to achieve optimal performance of the detachable coil system, it is important that a continuous infusion of an appropriate flush solution be maintained.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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 during a coil embolization to the meningeal artery, the scrub nurse felt resistance with a freeform mini freeform mini 1.5mm x 4cm coil (mcr091040, 31585344) while pushing in the coil into the pink sheath.Coil removed from rhv, and checked, it was not moving forward.Additional event information received on 18-aug-2025 indicated that a headway duo 156cm microcatheter was used.Ten coils were previously implanted during the procedure.There was no damage to the embolic coil or any device component.There was no anatomical tortuosity at the distal, aortic arch or at the iliofemoral regions.The device deficiency did not result in patient harm.Based on the product analysis of the freeform mini 1.5mm x 4cm received, the embolic coil was found stretched and damaged.

• Brand Name: CEREPAK FREEFORM
• Common Device Name: CEREPAK FREEFORM MINI DETACHABLE COIL SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS, INC.; calle circuito int norte 1820; parque industrial salvacar; juarez 32574 ; MX 32574
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 23062600
• Report Number: 3008114965-2025-00985
• Device Sequence Number: 21250390
• Product Code: KRD
• UDI-Device Identifier: 10886704082989
• UDI-Public: (01)10886704082989(17)280131(10)31585344
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K220040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

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: MCR091540
• Device Lot Number: 31585344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HEADWAY DUO 156CM MICROCATHETER.
• Patient Age: 43 YR
• Patient Sex: Male