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

Catalog Number	MCR092040
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
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.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 (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
As reported by a healthcare professional, during a tumor embolization, a freeform mini 2mm x 4cm coil (mcr092040, 31098100) failed to detach.There were no procedural delays due to the event.The procedure was successfully completed.There was no patient injury.Additional event information received on 07-apr-2025 indicated that the coil did not detach after attempting to use the mechanical detachment handle (mdh1, lot unknown) or manual break attempt.There were no relevant anatomical information including vessel characteristics (calcification/tortuosity).The procedure was completed by using another cerepak coil.
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
Manufacture ref# (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h3, h6 and h11.Complaint conclusion: as reported by a healthcare professional, during a tumor embolization, a freeform mini 2mm x 4cm coil (mcr092040, 31098100) failed to detach.There were no procedural delays due to the event.The procedure was successfully completed.There was no patient injury.Additional event information received on 07-apr-2025 indicated that the coil did not detach after attempting to use the mechanical detachment handle (mdh1, lot unknown) or manual break attempt.There were no relevant anatomical information including vessel characteristics (calcification/tortuosity).The procedure was completed by using another cerepak coil.A non-sterile freeform mini 2mm x 4cm coil was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and a manual break was attempted; however, it was not attempted at the proper location, as the manual break was performed above the manual break reference marks.The embolic coil was severely stretched and remained attached to the delivery system.The guidewire was found bent at 86.0cm from the distal end.Microscopic inspection was performed, and the embolic coil was still attached to the proximal key.No unintentional weld was noted on the loop-hole.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The issue reported regarding the failure to detach the embolic coil is confirmed.According to risk documentation, the inability to manually break the delivery system between the 2 manual break markers is a potential failure mode that can result in the user being unable to perform the detachment of the coil.With the limited information available, a conclusive cause cannot be determined; however, factors not described within the information available such as device manipulation, operator's technique, anatomical tortuosity, etc., may have contributed to the issue encountered.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.The stretched condition of the embolic coil and damages on the guidewire were not originally reported, and the exact time of occurrence cannot be determined; therefore, these damages are not considered related to the issue reported.As part of j&j medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent damages 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.The instructions for use (ifu) contain the following recommendations: in the rare event, that the detacher can¿t be used for detachment, the manual break method can be used: 1.Locate the manual break indicator (mbi) markers approximately 20 cm from the proximal end of the device.2.Using your thumb & forefinger, grip the delivery pusher with one hand precisely at the center of each of the mbi markers.3.Bend the proximal end of the pusher between the mbi markers approximately 90 degrees or until the tube snaps.If needed, continue bending and straightening until the tube separates and exposes the internal pull-wire.4.Ensure the delivery tube is straight outside the patient body starting from the vascular access sheath and that the proximal portion of the break remains in line with the remaining tube.While holding the distal end, pull the proximal end approximately 2-3 cm to release the coil.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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: 21874404
• Report Number: 3008114965-2025-00330
• Device Sequence Number: 8631879
• Product Code: KRD
• UDI-Device Identifier: 10886704083009
• UDI-Public: (01)10886704083009(17)260531(10)31098100
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup,Followup
• Report Date (Section B): 05/29/2025

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: 05/31/2026
• Device Catalogue Number: MCR092040
• Device Lot Number: 31098100
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 04/28/2025; 05/28/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 04/29/2025; 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MECHANICAL DETACHMENT HANDLE.
• Patient Sex: Unknown