MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL FREEFORM MINI 2MM X 4CM; CEREPAK FREEFORM MINI DETACHABLE COIL SYSTEM

Catalog Number	MCR092040
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (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 as indicated as ¿other¿ in this section as the reason for non-evaluation.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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2024-00442.
Event or Problem Description
As reported by the field, during a coil embolization, while placing a freeform min coil inside the aneurysm, no detachment marker was found at all under fluoro.Therefore, the physician didn¿t know when to detach the coil.The coil was removed, and case carried on.Two coils, a freeform mini 2mm x 6cm (mcr092060, 31162594) and a freeform mini 2mm x 4cm (mcr092040, 31162593) are being included in the complaint since it is not clear which one had the issue.Additional event information received on 29-apr-2024 indicated that there was no patient injury.The case was finished with another coil.There was a 3-minute procedure delay due to the event, the delay was not clinically significant.
Additional Manufacturer Narrative
Product complaint # (b)(4).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
Product complaint (b)(4) complaint conclusion: as reported by the field, during a coil embolization, while placing a freeform min coil inside the aneurysm, no detachment marker was found at all under fluoro.Therefore, the physician didn¿t know when to detach the coil.The coil was removed, and case carried on.Two coils, a freeform mini 2mm x 6cm ( mcr092060, 31162594) and a freeform mini 2mm x 4cm (mcr092040, 31162593) are being included in the complaint since it is not clear which one had the issue.Additional event information received on 29-apr-2024 indicated that there was no patient injury.The case was finished with another coil.There was a 3-minute procedure delay due to the event, the delay was not clinically significant.A non-sterile freeform mini 2mm x 4cm was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the embolic coil was found still attached to the delivery system and outside the introducer.The manual break was not attempted.The device was inspected under x-ray imaging, and the marker band was identified.A manufacturing record evaluation was performed for the finished device 31162594 number, and no non-conformances related to the malfunction were identified.The issue reported regarding the missing detachment marker could not be confirmed, as the marker was identified under x-ray imaging.It is possible that other clinical and procedural factors that cannot be replicated during the analysis may have contributed to the reported failure.As part of cerenovus quality process all devices are manufactured, inspected, and released to approved specifications.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) contained the following recommendation: the infusion microcatheter has two distal tip marker bands located three (3) cm apart.The detachable coil has a distal marker band three (3) cm from the detachment mechanism.To obtain proper positioning of the system for detachment under fluoroscopic guidance, align the radiopaque marker on the delivery tube just past the proximal marker band on the tip of the microcatheter.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).The lot number in the manufacturing record evaluation was submitted as 31162594.The correct lot number is 31162593.A manufacturing record evaluation was performed for the finished device 31162593 number, and no non-conformances related to the malfunction were identified.

• Brand Name: FREEFORM MINI 2MM X 4CM
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19203230
• Report Number: 3008114965-2024-00443
• Device Sequence Number: 7927410
• Product Code: KRD
• UDI-Device Identifier: 10886704083009
• UDI-Public: 10886704083009
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/18/2024

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: MCR092040
• Device Lot Number: 31162593
• 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: 04/23/2024
• Supplement Date Received by Manufacturer: 05/30/2024; 06/12/2024; 06/17/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 05/30/2024; 06/13/2024; 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• 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
• Patient Sex: Unknown