MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FILL COIL 4X12; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CF0412
Medical Device Problem Codes	Separation Failure (2547); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Procode: krd/hcg.Initial reporter phone: (b)(6).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.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 company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, during a coil embolization, 4x12 orbit galaxy coil (640cf0412, 30729835) detached half.It could not be detached completely, a new syringe was replaced, the coil still failed to detach.The physician retracted the coil and it detached outside of the patient¿s body.Then a new coil was switched to complete the surgery.There was no patient injury reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information received indicated that the syringe was able to successfully release the subsequent coil no additional intervention was needed.The procedure was delayed by 10 minutes due to the event and it was not clinically significant.The concomitant devices functioned as expected.Further clarification was received indicating that the coil prematurely detached.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).Complaint conclusion: as reported by the field, during a coil embolization, 4x12 orbit galaxy coil (640cf0412, 30729835) detached half.It could not be detached completely, a new syringe was replaced, but the coil still failed to detach.The physician retracted the coil and it detached outside of the patient¿s body.Then a new coil was switched to complete the surgery.There was no patient injury reported.Additional information received indicated that the syringe was able to successfully release the subsequent coil no additional intervention was needed.The procedure was delayed by 10 minutes due to the event and it was not clinically significant.The concomitant devices functioned as expected.Further clarification was received indicating that the coil prematurely detached.No additional information is available.A non-sterile 4x12 orbit galaxy coil was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and no apparent damage was observed.A microscopic inspection was performed, and it was noted that the embolic coil was not attached to the rest of the unit, and it was not returned to the laboratory for inspection.No elongation marks were noted in the gripper, which suggests that the coil was not mechanically detached from the unit.The statement "physician retracted the coil and it detached outside of patient body." can be confirmed since the device was returned without the coil component, however, it cannot be determined if the detachment was premature.The issue documented that the coil failed to detach cannot be evaluated through functional testing since the coil component was not returned; however, failure to detach is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issues from occurring.With the amount of information available and the evidence that could be obtained from the returned components, a conclusive cause cannot be determined.Other factors not described within the information available such as patient¿s anatomy or interaction with ancillary devices, may have contributed to the issue encountered rather than the manufacturing of the device.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.A manufacturing record evaluation was performed, and no non-conformances 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) do contain the following recommendations: tensile or compressive stresses can result in forward movement of the infusion catheter, delivery tube movement, and movement of some portion of the coil which can lead to improper coil detachment.Prepare the syringe with sterile saline solution as instructed in the syringe instructions for use.If the syringe was previously used to detach a coil, confirm the maximum number of coil detachments or attempts is not exceeded.Do not exceed position 3, green zone, as this could cause the syringe to lose calibration.If position 3, green zone, has been exceeded, do not reuse the syringe for additional coil detachments.Maintain the pressure in position 3, green zone for approximately 3 seconds.Rapidly decreasing pressure indicates that the coil has been detached; however, detachment must be confirmed under fluoroscopy.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 events were 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.

• Brand Name: OG TDL CMPLX FILL COIL 4X12
• 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 ; 3035526892
• MDR Report Key: 15751228
• Report Number: 3008114965-2022-00725
• Device Sequence Number: 17693032
• Product Code: KRD
• UDI-Device Identifier: 10886704030270
• UDI-Public: 10886704030270
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2022

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: 640CF0412
• Device Catalogue Number: 640CF0412
• Device Lot Number: 30729835
• 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: 10/26/2022
• Supplement Date Received by Manufacturer: 11/14/2022; 11/22/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 11/17/2022; 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2022
• 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