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	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that when the freeform mini 2mm x 4cm (mcr092040/31140703) was being introduced into the microcatheter resistance was noted.The coil was removed and inspected and it was attempted to be advanced again without resolution.The embolic coil was replaced, and the issue resolved.Additional event information indicated that the resistance was felt at the distal aspect of the introducer sheath.A stryker excelsior sl-10 microcatheter (non j&j) was used.A synchro wire and two coils were used with the microcatheter prior to the encountered resistance, and a coil after the encountered resistance.There was no necessity to remove nor replace the microcatheter.The target vessel was the posterior communicating artery, and there was tortuosity.The device did not appear damaged at any time.Nothing was noted to be obstructing the microcatheter.A continuous flush was maintained.
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was found stretched, meeting regulatory reporting criteria.Section d2b ¿ procode: krd/hcg 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 delivery system was returned inside the introducer sheath.The delivery wire was kinked in different locations along its entire length.The manual break was not attempted.The device was inspected under x-ray imaging, and the distal end of the embolic coil was found compacted and severely stretched.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The issue reported regarding the resistance noted while advancing the embolic coil was confirmed based on the compressed and stretched conditions mentioned above.It is possible that an appropriate continuous flush was not maintained, since according to the risk documentation, resistance / friction between microcoil system and the microcatheter is a potential issue that can occur due to a continuous saline flush not maintained while introducing the detachable coil system, and it can led to coil damage.With the limited information available, a conclusive cause cannot be determined; however, factors not described within the information available such as device manipulation, operator's technique, anatomical tortuosity, etc., may have contributed to the issue encountered.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.The kinked conditions found on the delivery wire were not originally reported.It is suggested that these could be the result of the manipulation of the device to overcome the resistance found during the advancement of the embolic coil through the microcatheter; therefore, this is not considered related to the issue reported.As part of cerenovus 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 damage 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.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following caution: ¿ if unusual friction is noticed during advancement or retraction of the detachable coil system through the introducer, open the rhv main valve, and partially withdraw the distal end of the introducer to expose its tip within the rhv.Tighten the rhv main valve, flush the y-connector of the rhv with sterile saline and verify that fluid exits the proximal end of the introducer.After flushing, reinsert the introducer into the infusion catheter hub.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.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: 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: 19583607
• Report Number: 3008114965-2024-00634
• Device Sequence Number: 15283252
• Product Code: KRD
• UDI-Device Identifier: 10886704083009
• UDI-Public: 10886704083009
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2024

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: 07/31/2026
• Device Catalogue Number: MCR092040
• Device Lot Number: 31140703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2023
• 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: EXCELSIOR SL-10® MICROCATHETER (STRYKER).; SYNCHRO2® 0.014¿ GUIDEWIRE (STRYKER).
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Hispanic
• Patient Race: White