MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME18 8MM X 30CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR180830
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization for a brain aneurysm, a micrusframe18 8mm x 30cm coil (mfr180830, 30532734) was used after microcatheter induction.The physician attempted to adjust the position of the unspecified microcatheter.Therefore, the complaint coil was re-sheathed, and attempted to be delivered again, however, as the delivery wire became difficult to push, the use was discontinued.It was replaced with another different product and the procedure was completed.Additional information received indicated that they were able to remove the device through the microcatheter.It was not necessary to remove the microcatheter.Nothing was noted to be obstructing the microcatheter.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.No excessive force was applied to the device.Based on the analysis of the device received, the embolic coil was found stretched.
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 noted as being stretched, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg initial reporter phone: (b)(6).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Complaint conclusion: as reported by the field, during a coil embolization for a brain aneurysm, a micrusframe18 8mm x 30cm coil ( mfr180830, 30532734) was used after microcatheter induction.The physician attempted to adjust the position of the unspecified microcatheter.Therefore, the complaint coil was re-sheathed, and attempted to be delivered again, however, as the delivery wire became difficult to push, the use was discontinued.It was replaced with another different product and the procedure was completed.Additional information received indicated that they were able to remove the device through the microcatheter.It was not necessary to remove the microcatheter.Nothing was noted to be obstructing the microcatheter.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.No excessive force was applied to the device.A non-sterile unit micrusframe18 8mm x 30cm was received inside of a pouch.The device was visually inspected, it could be noted that was tangled with itself.The core wire was found severely kinked.No other damages were found.The micrusframe18 8mm x 30cm was inspected under a microscope and it was noted that the embolic coil is stretched and tangled with the rest of the device.Also, the blue fiber could be noted broken.A manufacturing record evaluation was performed for the finished device 30532734 number, and no non-conformance's related to the reported complaint condition were identified.Cerenovus conducted a visual inspection and microscopic inspection.During the visual analysis, it could be noted that the device was tangled with itself and the core wire was found severely kinked.The embolic coil was inspected under a microscope, and it was found stretched and tangled with the rest of the device.Also, the blue fiber could be noted broken.The visual analysis of the returned sample determined that the core wire is severely kinked, and the embolic coil stretched and tangled with the rest of the device, these conditions may be the result of the resistance/friction felt reported by the customer.Due to this, the customer complaint ¿detachable coil delivery system (dcs)- resistance/friction-during advancement with no loss of cerebral target position¿ was confirmed.A manufacturing record evaluation was performed, and no non-conformance related to the reported complaint condition were identified.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following precautions: if unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw and examine the delivery catheter system.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failures and damages on the returned 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.

• Brand Name: MICRUSFRAME18 8MM X 30CM
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13153572
• Report Number: 3008114965-2022-00005
• Device Sequence Number: 12099260
• Product Code: KRD
• UDI-Device Identifier: 10886704078210
• UDI-Public: 10886704078210
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/04/2022

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: 02/29/2024
• Device Model Number: MFR180830
• Device Catalogue Number: MFR180830
• Device Lot Number: 30532734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED MICROCATHETER
• Patient Sex: Unknown