MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR181240
Medical Device Problem Codes	Positioning Problem (3009); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, sex, gender, weight, race, and ethnicity were not provided.Section d.2b: procode is krd/hcg.Section e.1: the initial reporter phone is not available / reported.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (31168427) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no internal actions related to device manufacture or inspection.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the limited information available and without the product available for analysis, the reported issue documented in the complaint could not be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined; however, it is possible that circumstances of the procedure and / or device manipulation / interaction may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered later.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 johnson & johnson medtech, or its employees that the report constitutes an admission that the product, johnson & johnson medtech, 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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during a coil embolization targeting a splenic artery aneurysm via double catheter technique, all devices were used in accordance with the instructions for use (ifu).Two (2) microcatheters, a leonis mova¿ microcatheter (sumimoto bakelite) and a breakthrough¿ microcatheter (boston scientific) were advanced to the target lesion using the parent plus® guide sheath (medikit) and a 5fr angiography catheter (unspecified brand).It was reported that ¿due to the deformed shape of the aneurysm,¿ a 12mm x 40cm micrusframe 18 (mfr181240 / 31168427) was used through the leonis mova¿ microcatheter and the micrusframe s through the breakthrough¿ microcatheter.The 12mm x 40cm micrusframe 18 coil inserted through the leonis mova did not have good engagement, the physician attempted to resheath the coil into the microcatheter for reposition.During the resheathing attempt, there was no resistance, ¿but a sensation of ¿snapping¿ was felt midway.After removal with the microcatheter, it was found that the coil had separated at the detachment point, and the detached coil was recovered from within the microcatheter.Unravel was not observed on the recovered coil.¿ another cerenovus col was placed after the 12mm x 40cm micrusframe 18 was removed.A total of ten (10) cerenovus coils were used without any issue.The procedure was successfully completed.Continuous flush was maintained during the procedure.There was no negative impact to the patient.On 25-feb-2025, additional information was received.The information indicated that the coil separated at the detachment zone on the device positioning unit.The embolic coil component was not fractured / separated into two pieces.The reported issue did not result in a reduced / restricted blood flow in the parent vessel.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 11-mar-2025.[additional information]: on 11-mar-2025, additional information was received.Per the information, the same leonis mova microcatheter was used to complete the procedure.Another 10mm x 34cm micrusframe 18 (mfr181034 / 30824768) was used.The information indicated that an ¿additional 15 to 20 minutes were needed to pull the coil with microcatheter from the patient¿s body and reinserting the microcatheter.It was not clinically significant delay.¿ updated sections.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: MICRUSFRAME
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 21521111
• Report Number: 3008114965-2025-00155
• Device Sequence Number: 8455318
• Product Code: KRD
• UDI-Device Identifier: 10886704078098
• UDI-Public: (01)10886704078098(11)231024(17)260930(10)31168427
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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: MFR181240
• Device Lot Number: 31168427
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2023
• 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: 5FR ANGIOGRAPHY CATHETER (UNSPECIFIED BRAND); BREAKTHROUGH¿ MICROCATHETER (BOSTON SCIENTIFIC); LEONIS MOVA¿ MICROCATHETER (SUMIMOTO BAKELITE); PARENT PLUS® GUIDE SHEATH (MEDIKIT)
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian