MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME10 5MM X 9.7CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR100509
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg the product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.This information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by the field, this was a stent assist coil embolization of recurrent right posterior communicating artery aneurysm.During the procedure a 5mm x 9.7 cm micrusframe10 (mfr100509, 30498377) was selected and prepped for use.Once in position, the coil would not detach and was deemed to be defective.It was removed from service and saved for investigation.There was no patient injury reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this medwatch: b4.A non-sterile micrusframe10 5mm x 9.7cm was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and no apparent damage was observed.The device was inspected under magnification, and it was found that the coil was already detached from the unit.The distal outer sheath had been softened, indicating that the resistance heating coil had been heated and the detachment process was already initiated.The embolic coil was not returned for evaluation.The electrical resistance of the micrusframe10 5mm x 9.7cm device was measured with a multimeter.The readings are within the specification range.Also, the device was connected to a lab sample detachment control box (dcb) dcb2000500 with the received enpower control cable, and the power was turned on.The system ready light was illuminating.Then, the detach button was pressed, and a beep sound was heard.A manufacturing record evaluation was performed for the finished device, and no non-conformances related to the reported complaint condition were identified.The customer complaint regarding a failure to detach was not confirmed, since the resistance heating was found already heated, and the coil was successfully detached from the unit.Also, the device met the specification range, and no abnormalities were found during the test.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated in the lab setting.Failure to detach is a known potential issue associated with the use of this device.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint were identified.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: ¿ verify that the microcoil delivery system is fully connected, and no faults are indicated on the dcb.If a fault exists, reseat all connections between the dpu, the dcb, and the connecting cable.If a fault still persists, replace the connecting cable.If this does not correct the error, replace the dcb.If the microcoil delivery system still continues to have a fault, retrieve the microcoil, re sheathing the microcoil system, and replace it with a new microcoil system.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint # (b)(4) section d9.The date of the device received was inadvertently omitted on the initial submission of the medwatch report.The device was received on 10/17/2022.

• Brand Name: MICRUSFRAME10 5MM X 9.7CM
• 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): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15624344
• Report Number: 3008114965-2022-00665
• Device Sequence Number: 6224835
• Product Code: KRD
• UDI-Device Identifier: 10886704077848
• UDI-Public: 10886704077848
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2022

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: 12/31/2023
• Device Model Number: MFR100509
• Device Catalogue Number: MFR100509
• Device Lot Number: 30498377
• 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: 10/18/2022
• Supplement Date Received by Manufacturer: 10/18/2022; 10/21/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 10/18/2022; 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2021
• 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 Age: 54 YR
• Patient Sex: Female