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

Catalog Number	FCX100407
Medical Device Problem Codes	Material Separation (1562); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
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.Section h3 - the device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.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 an unknown vessel, the physician used a uniform 4mm x 7.5 cm coil (fcx100407, 31154117).They tried twice to detach the coil with a mechanical detachment handle (mdh1, lot unknown) and it failed to detach.On third try, it seems the proximal wire of the coil (the part inside detacher) broke off.The coil did not detach, and they took it out of the patient.The piece that hospital claims to have broken off and the detacher were not saved and only the coil will be returned for analysis.Additional event information received on 03-sep-2025 indicated that this was the first coil they tried to use.There was no resistance mentioned.There was no report of embolic coil damage.There was no mention of any complexity with anatomy or patient.No patient injury was reported.No additional information is available.
Additional Manufacturer Narrative
Manufacturer ref # (b)(4).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3 and h11.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h7, h9 and h11.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h3, h6 and h11.Complaint conclusion: a healthcare professional reported that during a coil embolization to an unknown vessel, the physician used a uniform 4mm x 7.5 cm coil (fcx100407, 31154117).They tried twice to detach the coil with a mechanical detachment handle (mdh1, lot unknown) and it failed to detach.On third try, it seems the proximal wire of the coil (the part inside detacher) broke off.The coil did not detach, and they took it out of the patient.The piece that hospital claims to have broken off and the detacher were not saved and only the coil will be returned for analysis.Additional event information received on 03-sep-2025 indicated that this was the first coil they tried to use.There was no resistance mentioned.There was no report of embolic coil damage.There was no mention of any complexity with anatomy or patient.No patient injury was reported.No additional information is available.The device was returned to j&j medtech for further evaluation.A non-sterile uniform 4mm x 7.5 cm coil was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the delivery system was separated.The separation was noted at the proximal end of the support coil, exposing the complete puller wire from the main delivery tube.The embolic coil was no longer attached to the delivery system.The manual break was intact.Microscopic inspection revealed a fractured condition on the support coil exposing the lubricious sleeve and a stretched condition.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The issue reported regarding the broken wire is confirmed based on the damage observed.With the limited information reported, the root cause of such failure remains unknown; therefore, the issue reported regarding the failure to detach cannot be evaluated due to the severity of damages of the delivery system.The coil detachment was not originally reported, and the exact time of occurrence cannot be determined.Since it was stated that the embolic coil did not detach during the procedure, it is suggested that the detachment could have occurred during the handling post-procedure of the device.However, failure to detach issues are being addressed through j&j medtech quality systems.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: CEREPAK UNIFORM
• Common Device Name: CEREPAK UNIFORM 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: 22963014
• Report Number: 3008114965-2025-00957
• Device Sequence Number: 9590880
• Product Code: KRD
• UDI-Device Identifier: 10886704084013
• UDI-Public: (01)10886704084013(17)260831(10)31154117
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/12/2025

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 Expiration Date: 08/31/2026
• Device Catalogue Number: FCX100407
• Device Lot Number: 31154117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 09/22/2025; 10/01/2025; 11/11/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 10/06/2025; 10/29/2025; 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3007628272/10092025/R
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MECHANICAL DETACHMENT HANDLE.
• Patient Age: 39 YR
• Patient Sex: Female