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

Catalog Number	XCR120308
Medical Device Problem Codes	Separation Failure (2547); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, via a healthcare professional, that a freeform xsft 3mm x 8 cm (xcr120308/ 31162597) and a mechanical detachment handle (mdh1/ 102109430) were used for an endovascular coiling procedure.During the procedure, the user reported coil- failure to detach after attempting to use the handle detacher twice and manual break once.The physician then decided to remove the coil, however, the coil prematurely detached in the microcatheter upon removal.Multiple unsuccessful attempts were made to aspirate coil out of microcatheter.Therefore, the microcatheter was removed and the physician was required to reengage the aneurysm.The surgery was delayed by 45 minutes.The procedure was successfully completed.There was no reported injury to the patient.On 23-apr-2025, additional information was received.Summary: the target treatment site was an unruptured aneurysm of the right middle cerebral artery bifurcation.Vessel characteristics were described as ¿mild tortuosity.¿ the 45-minute delay was considered to be clinically significant ¿because microcatheter had to be removed and aneurysm had to be re engaged.¿ when removed, the coil did not appear to be stretched or damaged.The microcatheter used was a ¿prowler 14¿ (606151fx/ lot # unknown).The microcatheter did not appear to be damaged.To complete the surgery, another cerepak freeform xsft 3mm x 8cm (product code/ lot # unknown) was used and the microcatheter was switched to an excelsior sl-10(stryker).Regarding the patient¿s current status, their condition was reported as unchanged from ¿baseline.¿ the lot number for the mechanical handler was provided: 102109430.This device information has been updated in the initial note above.Prior to the alleged device failure, one coil was previously implanted.There was no resistance during the advancement of the device through the microcatheter or positioning difficulty in the aneurysm.The patient is a 65-year-old female with a medical history of hypertension.
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4) section d2b ¿ procode: krd/hcg.The device was discarded, therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 31162597 number, and no non-conformances related to the malfunction were identified.Failure to detach the cerepak coil could cause stretching, separation, and/or premature detachment, which could result in non-target site embolization, ischemia or infarct.Premature detachment in the microcatheter will require removal of both microcatheter and coil system as a unit with loss of target site, also with the potential for unintended target site embolization.There are clinical and procedural factors including vessel characteristics (i.E., tortuosity), device interaction, and operator technique, that may have contributed to the event rather than a device design or manufacturing issue.In this case, there were no reports of patient injury; however, it was reported the surgery was delayed by 45-minutes, to which the treating physician considered to be clinically significant.The severity is unknown.Based on this information, this event will be conservatively reported to the us fda under reporting criteria 21 cfr 803 with a classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.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.

• 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: 21917898
• Report Number: 3008114965-2025-00358
• Device Sequence Number: 15725023
• Product Code: KRD
• UDI-Device Identifier: 10886704083658
• UDI-Public: (01)10886704083658(17)260831(10)31162597
• 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
• Type of Report: Initial
• Report Date (Section B): 04/28/2025

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: 08/31/2026
• Device Catalogue Number: XCR120308
• Device Lot Number: 31162597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2023
• 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; PRESHAPED PROWLER14 45TIP 2MRK
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Hispanic
• Patient Race: White