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

Model 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	08/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: (b)(4).Initial reporter phone:(b)(6).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 4.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 to an approximate 4mm aneurysm at the left cavernous sinus, a 4x8 orbit galaxy xtrasoft coil (640cx0408, 30697746) was delivered within a non j&j microcatheter (mc).When the coil advanced one half of it within microcatheter, it was impeded in mc and could not advance any more.The physician withdrew the coil a little and tried to deliver it again, but it still could not be pushed.The doctor retracted the coil and observed it released in microcatheter.A new coil was switched to complete the surgery.There was no patient injury report.Additional information received indicated that a frepass®microcatheter inner diameter 0.0165 mc was used.The delivery wire was able to pass through the microcatheter prior to the encountered resistance.The mc was not damaged during manipulation of the coil or noticed to be damaged upon removal from the patient.The coil did not appear damaged at any time.There was nothing noted to be obstructing the microcatheter.A continuous flush on the microcatheter was maintained.No excessive force was applied to the device.There were no procedural delays due to the event.The blood vessels were in good condition.
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 to an approximate 4mm aneurysm at the left cavernous sinus, a 4x8 orbit galaxy xtrasoft coil (640cx0408, 30697746) was delivered within a non j&j microcatheter (mc).When the coil advanced one half of it within microcatheter, it was impeded in mc and could not advance any more.The physician withdrew the coil a little and tried to deliver it again, but it still could not be pushed.The doctor retracted the coil and observed it released in microcatheter.A new coil was switched to complete the surgery.There was no patient injury report.Additional information received indicated that a freepass®microcatheter inner diameter 0.0165 mc was used.The delivery wire was able to pass through the microcatheter prior to the encountered resistance.The mc was not damaged during manipulation of the coil or noticed to be damaged upon removal from the patient.The coil did not appear damaged at any time.There was nothing noted to be obstructing the microcatheter.A continuous flush on the microcatheter was maintained.No excessive force was applied to the device.There were no procedural delays due to the event.The blood vessels were in good condition.A non-sterile og cmplx xtrasoft coil 4x8 was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was noted that the gripper was protruding from the introducer.The device was inspected under microscopic magnification, and it was found that a kinked condition opens the introducer at the point where the gripper protrudes.The gripper was noted to have an elongation.Also, the coil component was inspected under microscopic magnification, and it was noted that the coil was broken, and only the proximal section remains attached to the rest of the device.A manufacturing record evaluation was performed for the finished device 30697746 number, and no non-conformances related to the malfunction were identified.Based on the broken condition noted in the coil, it can be determined that the coil was mechanically detached from the unit; this confirms the customer's allegation regarding the coil's premature detachment.The impeded condition of the coil in the microcatheter, as documented in the complaint, could not be tested due to the conditions in which the device was received.However, such conditions can be reasonably considered secondary to the issue encountered during the procedure.Is possible that force may have inadvertently been applied since the complaint documented that the coil became detached when removed.However, other factors not described in the event description may have contributed to the issue encountered during the procedure.With the information available, there is no indication that the issue reported in the complaint results from a defect inherently related to the device.Based on this, the customer complaint regarding impeded condition was able to be confirmed.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) do contain the following recommendations: do not use a coil system showing signs of damage.Increase the pressure in the syringe by rotating the syringe knob clockwise until the gauge indicator enters position 3, green zone.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• 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): CODMAN & SHURTLEFF, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15335301
• Report Number: 3008114965-2022-00580
• Device Sequence Number: 17763750
• Product Code: KRD
• UDI-Device Identifier: 10886704030638
• UDI-Public: 10886704030638
• 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): 11/03/2022

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: 10/31/2023
• Device Model Number: 640CX0408
• Device Catalogue Number: 640CX0408
• Device Lot Number: 30697746
• 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: 08/18/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2021
• 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: FREPASS®MICROCATHETER MICROCATHETER
• Patient Sex: Unknown