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

Catalog Number	XCR123505
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).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.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 the anterior cerebral artery, a freeform xsft 3.5mm x 5 cm coil (xcr123505, 31146338) failed to detach after multiple attempts.The surgery was delayed due to the reported event by 15-20 minutes.The procedure was successfully completed.Additional event information received on 21-aug-2025 indicated that a prowler 14 microcatheter was used.This was the first coil to be implanted.There was no resistance during advancement of the device through the microcatheter or positioning difficulty in the aneurysm.Two attempts were made using the mechanical detachment handle (mdh1, 102109430).There was no damage to the embolic coil or any device component.The vessel was not excessively tortuous or with acute bends.The 15 to 20 minutes procedural delay did not result in any adverse patient consequence.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).A healthcare professional reported that during a coil embolization to the anterior cerebral artery, a freeform xsft 3.5mm x 5 cm coil (xcr123505, 31146338) failed to detach after multiple attempts.The device was returned to j&j medtech for further evaluation.A non-sterile freeform xsft 3.5mm x 5 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 was still attached to the delivery system.The proximal end of the embolic coil was severely stretched.Microscopic inspection revealed dried blood residues on the proximal engagement key and occluding the loop-hole.A manufacturing record evaluation was performed for the finished device 31146338 number, and no internal actions 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.The occluded condition of the proximal key engagement suggests that the saline flush could have been insufficient, since according to risk documentation, an insufficient continuous saline flush can increase resistance/friction between microcoil system and the microcatheter which can result in potential degradation of device performance and accidental mechanical product damage.The stretched condition of the embolic coil is suspected to be the result of the handling post-procedure of the cerepak system, as according to the information received, there was no damage on the embolic coil; therefore, this condition is not considered related to the issue reported.This issue is being address through j&j medtech quality system.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Updated sections on this medwatch: b4, d9, g3, g6, h2, h3, h6 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, h7, h9 and h11.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 XTRASOFT 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: 22939404
• Report Number: 3008114965-2025-00943
• Device Sequence Number: 15932701
• Product Code: KRD
• UDI-Device Identifier: 10886704083764
• UDI-Public: (01)10886704083764(17)260731(10)31146338
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 10/29/2025

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: 07/31/2026
• Device Catalogue Number: XCR123505
• Device Lot Number: 31146338
• 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: 08/14/2025
• Supplement Date Received by Manufacturer: 10/08/2025; 10/01/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/10/2025; 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2023
• 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
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Hispanic
• Patient Race: White