MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ORBIT GALAXY XTRASOFT; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CX3509
Medical Device Problem Codes	Positioning Failure (1158); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was found kinked, meeting us regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section d2b ¿ procode: krd/hcg.Section e1.Initial reporter phone: (b)(6).A non-sterile og cmplx xtrasoft coil 3.5x9 was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and the coil was noted to be outside from the introducer.The device was inspected under microscopic magnification, and multiple kinked conditions were found on the coil however, it was still attached to the gripper.The issue documented in the complaint that there was an impeded condition felt during the advancement of the coil through the microcatheter could not be evaluated through proper functional test since the multiple kinked conditions found on the coil prevented the ability to move the coil through the introducer.The coil kinking was not originally reported in the complaint.Such damage suggest that excessive force was inadvertently applied during the attempts to withdraw and re-insert the device.It is possible that clinical and procedural factors, including device manipulation and operator's technique, may have contributed 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.A manufacturing record evaluation was performed for the finished device 31178987 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.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is proposed at this time.It should be noted that product failure is multifactorial.The instructions for use contain the following precautions and warnings: ¿ 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.¿ during coil retraction, verify under fluoroscopy that a one-to-one relationship exists between the delivery tube and the coil.If not, the coil has been stretched, which could lead to premature detachment or coil fracture.If the one-to-one relationship does not exist, remove the infusion catheter and the detachable coil as an assembly and replace.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.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.
Event or Problem Description
As reported by the field, during a coil embolization to the anterior communicating aneurysm (acom), the unspecified microcatheter (mc) kicked back (moved out of the aneurysm) when an orbit galaxy xtrasoft coil (640cx3509, 31178987) was delivered in the proximal of the microcatheter.Therefore, the physician only retracted the coil and then placed the microcatheter at the target site and then delivered the same coil again, the coil was impeded in middle section of the microcatheter and could not advance any more.The physician retracted the coil and switched a new one to complete the surgery.The microcatheter was not replaced.There was no patient injury reported.Additional event information received on 18-oct-2024 indicated that event did not result in any undue procedural delay that could be considered clinically significant.The device did not appear to be damaged at any time.There was nothing noted to be obstructing the microcatheter.A continuous flush was maintained.Based on the product analysis of the device received, the embolic coil was found kinked.

• Brand Name: ORBIT GALAXY XTRASOFT
• 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: 20723262
• Report Number: 3008114965-2024-01143
• Device Sequence Number: 20455285
• Product Code: KRD
• UDI-Device Identifier: 10886704030690
• UDI-Public: (01)10886704030690(17)250930(10)31178987
• 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
• Report Date (Section B): 11/19/2024

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: 09/30/2025
• Device Catalogue Number: 640CX3509
• Device Lot Number: 31178987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2023
• 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: MICROCATHETER (UNSPECIFIED BRAND)
• Patient Sex: Unknown