MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FRAME COIL 8X30; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CR0830
Medical Device Problem Codes	Difficult to Advance (2920); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during an endovascular embolization procedure, while advancing the complaint coil, an 8mm x 30cm orbit galaxy complex frame (640cr0830 / 30848872), there was ¿so much resistance while pushing the coil in the microcatheter,¿ when the coil was removed, it became separated from the pusher wire.The procedure was delayed by 10 minutes.The complaint coil was removed.The procedure was successfully completed.There was no report of any negative patient impact.On (b)(6)2 023, additional information was received.The information indicated that the procedure was targeting an internal carotid artery (ica) occlusion.The information indicated that the coil did not prematurely detach at the detachment zone on the device positioning unit.No additional intervention was required; the coil was removed instantly.The event did not result in a reduced / restricted blood flow in the parent vessel.There was no evidence of thrombosis.The microcatheter used was a competitor product.Adequate continuous flush was maintained through the microcatheter.The complaint coil was replaced with an 8mm x 24cm orbit galaxy complex fill coil (640cf0824).The physician did not think the 10-minute delay in the procedure to be clinically significant.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, 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 (30848872) 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.
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 10-may-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 8mm x 30cm orbit galaxy complex frame coil was received contained in the decontamination pouch.Visual inspection was performed.The hypo-tube was observed broken into two (2) pieces.The device was inspected under the microscope.Under magnification, the proximal end of the coil was observed slightly stretched, still attached to the gripper.The blue fiber was noted to be exposed.A review of manufacturing documentation associated with this lot (30848872) 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 the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The issue documented in the complaint that the coil became separated from the pusher wire was not confirmed since the embolic coil was found still attached to the gripper.The issue regarding the resistance felt through the advancement of the embolic coil cannot be evaluated through functional test due to the broken condition of the hypo-tube, and the introducer not being returned for evaluation.The hypo-tube breakage and coil stretching were not originally reported in the complaint.Such damages suggest that excessive force was inadvertently applied during the attempts to advance the embolic system.According to the event description, strong resistance was felt during the advancement of the coil; and as stated in the risk documentation, fractures, separations, and coil stretching are potential failure modes that can occur during embolic coil placement due to excessive manipulation of the system, unfavorable coil placements, and/or coil entanglement.Therefore, the issue documented that there was ¿so much resistance while pushing the coil in the microcatheter¿ was confirmed.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: ¿ never advance, withdraw, or torque the delivery tube against resistance without first determining the cause of resistance under fluoroscopy.Manipulation of the delivery tube against resistance can cause damage and/or premature detachment of the coil.¿ if friction is noted with any subsequent detachable coil system, carefully examine the detachable coil system and the infusion catheter for possible damage.Replace both if necessary.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.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 8X30
• 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. (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: 16792432
• Report Number: 3008114965-2023-00238
• Device Sequence Number: 20253839
• Product Code: KRD
• UDI-Device Identifier: 10886704030454
• UDI-Public: 10886704030454
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2023

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 Model Number: 640CR0830
• Device Catalogue Number: 640CR0830
• Device Lot Number: 30848872
• 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: 04/09/2023
• Supplement Date Received by Manufacturer: 05/10/2023; 05/17/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 05/10/2023; 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2022
• 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 Age: 67 YR
• Patient Sex: Male