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

Catalog Number	FCX100626
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
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.Per the information received on 28-apr-2025 and 29-apr-2025, the remaining cerenovus coils did not detach despite several attempts using the detachment handle and manual break.The coils were removed without incident, no surgical intervention was required, and no patient harm resulted from the alleged device malfunctions.Additionally, it was reported there was a procedural delay, however, the cause of the delay was due to ¿access issues and tortuous anatomy.¿ based on this information, this event does not meet us fda reporting criteria as a serious injury.The file will be re-reviewed if additional information is received at a later date.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
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
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 6mm x 26 cm coil was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and although the manual break was attempted at the proper location, the embolic coil remained attached to the delivery system.The proximal end of the pull wire was exposed.A microscopic inspection was performed, and multiple kinked conditions was noted on the embolic coil.No damages were noted on the proximal key engagement nor unintentional weld was noted at the loop-hole.The main delivery tube was bent back and forth and separated in several locations to expose the pull wire.The coil detached after the main delivery tube was separated 15.8cm from the distal manual break indicator.A manufacturing record evaluation was performed for the finished device 31173105 number, and no non-conformances related to the malfunction were identified.The issue reported regarding the failure to detach is confirmed based on the attached condition of the embolic coil to the delivery unit after activating the manual break.With the information available, the root cause of the failure encountered cannot be determined.It is possible that clinical and procedural factors, including device manipulation, may have contributed to the reported failure.There is no indication that the issues reported in the complaint result from a defect inherently related to the cerepak device.The kinked conditions on the embolic coil were not originally reported; however, these damages could be the result of the manipulation exerted to remove the device from the anatomy and/or handling post-procedure.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.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: 1.Remove the detacher from the protective packaging and place it within the sterile field.The detacher is packaged separately for single patient use only.2.Confirm again under fluoroscopy that the coil alignment marker of the delivery tube creates a ¿t¿ with the proximal marker of the microcatheter.3.Verify that the rhv is firmly locked around the delivery tube to ensure that the coil does not move during connection process.Ensure the delivery tube is straight between the rhv and the detacher.4.Hold the delivery tube approximately 3 inches from proximal end and bring the detacher over the delivery tube until a firm stop is felt.5.Maintain the delivery tube position within the detacher and use a thumb to pull back the slider on the detacher.6.Continue to pull on the slider until end of travel or a click is heard.Gently release the slider until it returns to starting position or a second click is heard.Remove detacher by slowly withdrawing it from the delivery tube.Note: detacher must remain in sterile field until the procedure is completed.7.Fluoroscopically verify that the coil is detached by gently pulling back the delivery tube approximately 1cm.If the coil has detached, remove the delivery tube from the microcatheter.8.If the coil has not detached, repeat steps 3-7.If 2 unsuccessful detachments occur, discard the detacher and proceed to the manual break section.9.Repeat steps 1-8 until the procedure is completed.Discard the detacher.Caution: always perform fluoroscopic verification of detachment prior to withdrawing the delivery system fully.Failure to do so may lead to an embolic complication.10.After detaching the coil, remove the delivery tube from the microcatheter and discard.11.Repeat the above sequence for all additional coils until the procedure is complete.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 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: 21987172
• Report Number: 3008114965-2025-00423
• Device Sequence Number: 17262659
• Product Code: KRD
• UDI-Device Identifier: 10886704084051
• UDI-Public: (01)10886704084051(17)260930(10)31173105
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: FCX100626
• Device Lot Number: 31173105
• 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; 06/04/2025
• 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: 10/09/2023
• 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.
• Patient Sex: Unknown