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

Catalog Number	FCX180510
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, via a healthcare professional, that five cerepak uniform coils were used for an endovascular embolization procedure: uniform 7mm x 30 cm (fcx100730/ 31127140), uniform 7mm x 30 cm (fcx100730/ 31207071), uniform 6mm x 26 cm (fcx100626/ 31177724), uniform 6mm x 26 cm (fcx100626/ 31173105), a uniform xl 5mm x 10 cm (fcx180510/ 31178183), and a mechanical detachment handle (mdh1/ lot # unknown).During the procedure, the user reported failure to detach for all five coils.The physician felt the failure to detach was due to patient tortuous anatomy.It was also reported, ¿one coil is partially hanging in ica around site.¿ additional information was received on 29-apr-2025.Summary: per the information, the microcatheter was a prowler lpes (product code/ lot # unknown).Regarding what is meant by ¿one coil is partially hanging in ica around site,¿ it was reported,¿ one coil did detach once the system relaxed and was not under so much tension.¿ one coil was successfully implanted during this case.Regarding whether resistance was encountered during advancement of the devices through the microcatheter or positioning difficulty in the aneurysm, it was reported, ¿much tension and difficulty was presented for access in this case.¿ one attempt was made using the detachment handle, then manual break was attempted.There was no damage to embolic coils noted.The target vessel was the internal carotid artery (ica).The event did not result in patient harm.It was further reported, ¿prolonged several procedures and several hours due to access issues and tortuous anatomy.¿.
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.Per the additional information received on 29-apr-2025, it was disclosed that one of the cerepak coils did detach at the internal carotid artery (ica), the target location.While clarification of the statement, ¿one coil is partially hanging in ica around site,¿ is still pending, it appears the detached coil protruded out of the aneurysm into the parent vessel.Coil protrusion into parent vessel could result in non-target site embolization, ischemia or infarct or may require additional intervention.The intervention provided to address the coil protrusion was not disclosed, however, common techniques include repositioning, retrieval, stent placement, and/or anticoagulation therapy to prevent thrombus formation.The specific management approach depends on the severity of the protrusion, the presence of symptoms, and the patient's overall condition.Since the severity of this event is unknown, this event will be conservatively reported to the us fda reporting under criteria 21 cfr 803 with the classification of ¿serious injury.¿ 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 (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.
Additional Manufacturer Narrative
Manufacture ref# (b)(4).Updated sections on this med watch: b4, b5, d9, g3, g6, h2 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, h3, h6 and h11.The device was returned to j&j medtech for further evaluation.A non-sterile uniform xl 5mm x 10 cm coil was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and as described in the event, the manual break was attempted at the proper location, and the embolic coil was not attached to the delivery system.The loop-hole was inspected under magnification, and no unintentional weld was noted.A manufacturing record evaluation was performed for the finished device 31178183 number, and no non-conformances related to the malfunction were identified.The issue reported regarding the embolic coil protruding into the parent vessel cannot be evaluated through functional testing since the reported issue is specific to the patient and procedure at the time of occurrence and cannot be replicated in the laboratory.Additionally, there are no abnormalities or damages observed in the returned device that may have contributed or be secondary to the issue reported.There is no indication that the issue reported in the complaint is a result of 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 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 caution: always perform fluoroscopic verification of detachment prior to withdrawing the delivery system fully.Failure to do so may lead to an embolic complication.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 UNIFORM
• Common Device Name: CEREPAK UNIFORM XL 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: 21987104
• Report Number: 3008114965-2025-00421
• Device Sequence Number: 11834244
• Product Code: KRD
• UDI-Device Identifier: 10886704084464
• UDI-Public: (01)10886704084464(17)260930(10)31178183
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 06/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: FCX180510
• Device Lot Number: 31178183
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 05/15/2025; 05/29/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 05/23/2025; 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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; PROWLER LPES MICROCATHETER
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown