MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME18 10MM X 34CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR181034
Medical Device Problem Codes	Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization of the renal artery aneurysm, a micrusframe 18 10mm x 34cm coil (mfr181034, l16838) was used as a framing coil for the first.At the time of coil placement, and there was a strong resistance felt between the complaint product and the unspecified catheter at the place where the coil came out about 3 cm from the catheter.The complaint product became unraveled.After that, the complaint product was removed, and the procedure successfully completed with other coils.There was no health hazard to the patient.It was unclear if a continuous flush was done.The lesion is unknown.
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.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.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).Updated section on this medwatch report: b4, b5, e1, e2, e3, g3, g6, h2, h6 and h10.Section b5: additional information received indicated that the resistance was first felt during coil advancement.There was no damage to the microcatheter reported.Nothing was noted to be obstructing the microcatheter.No excessive force was applied to the device.There was no prolongation to the procedure due to the event.Section e1.Initial reporter phone: (b)(6).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).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.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).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during a coil embolization of the renal artery aneurysm, a micrusframe18 10mm x 34cm coil ((b)(4), l16838) was used as a framing coil for the first.At the time of coil placement, and there was a strong resistance felt between the complaint product and the unspecified catheter at the place where the coil came out about 3 cm from the catheter.The complaint product became unraveled.After that, the complaint product was removed, and the procedure successfully completed with other coils.There was no health hazard to the patient.It was unclear if a continuous flush was done.The lesion is unknown.Additional information received indicated that the resistance was first felt during coil advancement.There was no damage to the microcatheter reported.Nothing was noted to be obstructing the microcatheter.No excessive force was applied to the device.There was no prolongation to the procedure due to the event.Visual analysis was performed on the photo received for this complaint file.The device could be noted connected to another's company hemostasis valve.It can be determined that the embolic coil of the micrusframe18 10mm x 34cm has a kinked condition.The core wire could be noted with a kinked condition and also could be noted protruding from the introducer.Residues of blood could be noted on the device.No other damages could be noted.A non-sterile unit micrusframe10 7mm x 30cm was received inside of a pouch.The device was visually inspected, and the core wire was found kinked at 63 inches and protruded from the introducer at 69 inches from the proximal end.Embolic coil was found to be partially outside of the introducer.Embolic coil was inspected under a microscope, and a kink was observed on the nearest part to the introducer.Reddish material residues were observed along the coil length.No stretched/unraveled sections were observed.The functional test could not be performed due to the damages observed in the core wire and the coil.A manufacturing record evaluation was performed, and no non-conformances related to the complaint were found during the review.The device was returned to cerenovus for further evaluation.During the visual analysis, the core wire was found kinked at 63 inches and protruding from the introducer at 69 inches from the proximal end.Additionally, an embolic coil was found partially out of the introducer.The embolic coil was inspected under a microscope, and a kink was observed on the nearest portion to the introducer.No stretched/unraveled sections were observed.Additionally, residues of reddish material were observed along the coil length.Customer complaint was confirmed due to the findings observed, however, stretched/unraveled condition could not be confirmed.The event description and device analysis do not provide clear insight into the root cause and/or exact contributing factors that may have resulted in the observed failure mode.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.If the microcoil system becomes immobile in the infusion microcatheter, apply a gentle push-pull motion to free it.If unsuccessful, remove both microcatheter and microcoil system together as a unit and replace with new devices.Assignment of root cause for the events 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.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.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 10MM X 34CM
• 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: 13010672
• Report Number: 3008114965-2021-00675
• Device Sequence Number: 1726812
• Product Code: KRD
• UDI-Device Identifier: 10886704077213
• UDI-Public: 10886704077213
• 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,Followup,Followup,Followup
• Report Date (Section B): 02/22/2022

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: 08/31/2022
• Device Model Number: MFR181034
• Device Catalogue Number: MFR181034
• Device Lot Number: L16838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2021
• Supplement Date Received by Manufacturer: 12/17/2021; 01/11/2022; 02/17/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 01/06/2022; 01/27/2022; 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2019
• 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 CATHETER
• Patient Sex: Unknown