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

Catalog Number	MFR100412
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 b.3: date of event: the date of the event was not reported / known.Section d.2b: procode is krd/hcg.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 4mm x 11.5cm micrusframe 10 was received contained in the decontamination pouch.Visual inspection was performed.The resheathing tool was observed broken.Microscopic inspection was performed.The embolic coil was found protruding from the introducer and was in severely stretched condition.The complaint documented that the coil could not be removed was confirmed based on the multiple damages noted on the returned device.These damages could be the result of the difficulties experienced during the device removal from packaging.It is possible that clinical and procedural factors, including device manipulation and operator's technique, may have contributed to the reported failure.Stretching can occur during procedure handling where force may have been inadvertently applied.Coil stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issues from occurring.There is no indication that the issue reported is a result of a defect inherently related to the device.A review of manufacturing documentation associated with this lot: (31073024) 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.As part of johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that multiple factors could cause product failure.The instruction for use (ifu) contains the following precaution: do not bend the device positioning unit (dpu) wire as the device is pulled from the packaging hoop as this may result in damage to the device.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.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 an issue with two (2) coils: a 4mm x 11.5cm micrusframe 10 (mfr100412 / 31073024) and a 7mm x 30cm micrusframe 10 (mfr100730 / 30762308) that could not be removed during an endovascular embolization procedure.It was reported that additional information related to the complaint is not available.The complaint devices were returned for evaluation and analyses.The product investigations were completed on 08-jul-2025.Based on the completed product investigation, the product investigation related to the 4mm x 11.5cm micrusframe 10 (mfr100412 / 31073024) meets reportability criteria under 21 cfr 803 with a classification of ¿malfunction.¿.

• 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 949788-2078
• MDR Report Key: 22449360
• Report Number: 3008114965-2025-00698
• Device Sequence Number: 20981864
• Product Code: KRD
• UDI-Device Identifier: 10886704077817
• UDI-Public: (01)10886704077817(17)260630(10)31073024
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 07/08/2025

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: 06/30/2026
• Device Catalogue Number: MFR100412
• Device Lot Number: 31073024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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
• Patient Sex: Unknown