MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 4X8; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CX0408
Medical Device Problem Codes	Failure to Advance (2524); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during an endovascular embolization, an orbit galaxy xtrasoft coil (640cx0408, 31074781) became impeded in the proximal end of a prowler select lpes microcatheter (606s155x, 30763318) and could not advance any more.The doctor withdrew the coil, it was found that the coil was detached in the microcatheter (mc) prematurely and the coil remained in microcatheter.The physician removed the coil and microcatheter from the patient and replaced them with a new coil and a new microcatheter to complete the procedure.There was no patient injury reported.Additional event information received on 17-jul-2024 indicated that they were able to torque the device.There was no evidence of physical material within the device.No other devices were successfully used with the concomitant device prior to the encountered resistance.The microcatheter did not kink.There were no procedural delays due to the event.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1.Initial reporter phone: (b)(6).Section h3 - the device is available to be returned for evaluation and testing.However, it has not been received to date.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.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complaint conclusion: as reported by the field, during an endovascular embolization, an orbit galaxy xtrasoft coil (640cx0408, 31074781) became impeded in the proximal end of a prowler select lpes microcatheter (606s155x, 30763318) and could not advance any more.The doctor withdrew the coil, it was found that the coil was detached in the microcatheter (mc) prematurely and the coil remained in microcatheter.The physician removed the coil and microcatheter from the patient and replaced them with a new coil and a new microcatheter to complete the procedure.There was no patient injury reported.Additional event information received on 17-jul-2024 indicated that they were able to torque the device.There was no evidence of physical material within the device.No other devices were successfully used with the concomitant device prior to the encountered resistance.The microcatheter did not kink.There were no procedural delays due to the event.A non-sterile orbit galaxy xtrasoft coil was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and no apparent damage was observed.The device was inspected under magnification, and it was found that the coil was no longer attached to the gripper and this was not returned for evaluation.No elongation marks were found in the gripper.The issue reported regarding the coil being impeded in the microcatheter could not be evaluated through functional testing since the coil must still be attached to the gripper to perform a functional analysis; however, the issue regarding the premature detachment of the coil was confirmed since the coil was no longer attached to the returned gripper component.No damages were found on the device which indicates the detachment occurred prematurely as a result of a device failure.According to the risk documentation, premature detachment of the embolic coil assembly from the delivery system is a potential failure that can occur during embolic coil placement due to manipulation of the system against resistance.No further evaluation of contributing factors can be conducted without the embolic coil.It is possible that other clinical and procedural factors not described in this complaint may have contributed to the reported failure.A manufacturing record evaluation was performed for the finished device 31074781 number, and no non-conformances related to the malfunction were identified.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Therefore, no capa activity is required.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) contain the following precaution: 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.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: OG CMPLX XTRASOFT COIL 4X8
• 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 ; 3035526892
• MDR Report Key: 19793809
• Report Number: 3008114965-2024-00714
• Device Sequence Number: 4144909
• Product Code: KRD
• UDI-Device Identifier: 10886704030638
• UDI-Public: (01)10886704030638(11)240703(17)250430(10)31074781
• 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
• Report Date (Section B): 08/28/2024

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: 04/30/2025
• Device Catalogue Number: 640CX0408
• Device Lot Number: 31074781
• 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: 07/03/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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: PROWLER SELECT LPES
• Patient Sex: Unknown