MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FRAME COIL 7X25; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CR0725
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section d.2b: procode is krd/hcg.Section e.1: the initial reporter phone and email address are not available / reported.Section h.3: 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.A review of manufacturing documentation associated with this lot (30842969) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.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 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.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 that during an endovascular embolization procedure, there was resistance while advancing the complaint coil, a 7mm x 25cm orbit galaxy complex frame coil (640cr0725 / 30842969) inside the concomitant microcatheter to the aneurysm site.The coil was removed and replaced.The procedure was reported be successfully completed with a 5-minute delay.There was no negative patient impact.On 08-nov-2023, additional information was received.The information indicated the target vessel was the anterior communicating artery (acom) with tortuous anatomy.That the resistance was first felt during the device advancement inside the concomitant microcatheter (competitor device) at mid-shaft.A continuous flush was maintained through the microcatheter.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rotating hemostasis valve (rhv) during the advancement.Nothing was noted to be obstructing the microcatheter.Per the information, after the reported issue another 7mm x 25cm orbit galaxy complex frame coil (640cr0725) was used with the same microcatheter.The information indicated that the microcatheter was removed to remove the complaint coil.Based on the additional information received on 08-nov-2023, the event has been deemed usfda reportable under 21 cfr 803 with a classification of ¿malfunction.¿.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received in the product analysis lab on 23-nov-2023.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigation finding of the returned device.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 7mm x 25cm orbit galaxy complex frame coil was received contained in the decontamination pouch.Visual inspection was performed.The hypotube was observed kinked.No other damages were observed.The device underwent microscopic inspection.Under magnification, the embolic coil was observed still inside the introducer and in good condition (i.E.No kinks, no stretch or with non-concentric loops).No damage was observed on the introducer.A review of manufacturing documentation associated with this lot (30842969) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points along the manufacturing process to prevent device damages from leaving the facility.The impeded condition of the coil in the microcatheter, as documented in the complaint, could not be tested since the conditions in which the hypo-tube was received prevented the advancement through the introducer.It is possible that clinical and procedural factors, including device manipulation and operator's technique, may have contributed to the reported failure.With the limited information available, the root cause remains speculative, however, there is no indication that the issues encountered during the procedure are a result of a defect inherently related to the device.The kinked conditions of the hypo-tube were not originally reported, and these are suspected of having appeared during the handling of the device during the withdrawal.These conditions are not considered related to the reported failure.According to the risk documentation, delivery tube / embolic coil not pushing through the microcatheter is a potential issue that can occur during coil placement due to 1) excessively tortuous anatomy; or 2) clot formation in the microcatheter.With the limited information available, the root cause remains speculative, however, there is no indication that the issues encountered during the procedure are a result of a defect inherently related to the device.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendation: ¿ 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.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.Updated sections: b.4, g.3, g.6.H.2, h.3, h.6, and h.10.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: OG TDL CMPLX FRAME COIL 7X25
• 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. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 18145832
• Report Number: 3008114965-2023-00837
• Device Sequence Number: 17896479
• Product Code: KRD
• UDI-Device Identifier: 10886704030447
• UDI-Public: 10886704030447
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K093973
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2024

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: 05/31/2024
• Device Catalogue Number: 640CR0725
• Device Lot Number: 30842969
• 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: 11/08/2023
• Supplement Date Received by Manufacturer: 11/23/2023; 01/02/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 11/26/2023; 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• 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