MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FRAME COIL 9X30; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CR0930
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization to the basilar artery, an orbit galaxy coil (640cr0930, 31053583) became impeded in the middle section of the prolwer select 14 microcatheter (mc) and could not advance any more.The physician retracted the coil and switched to a new one to complete the surgery.The microcatheter was not replaced.There was no patient injury reported.Additional event information received on 25-apr-2024 indicted that there appeared to be no damage to the device.There was nothing obstructing the microcatheter.A continuous flush was maintained.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.Based on the product analysis of the device received, the embolic coil was found stretched.
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 stretched, meeting 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 9mm x 30cm orbit galaxy tdl complex frame was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and multiple kinked conditions were noted on the hypo-tube.The device was inspected under microscopic magnification, and the proximal end of the coil was found stretched, and still attached to the gripper.The blue fiber was noted to be exposed.The issue documented in the complaint that there was resistance 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 hypo-tube prevented the ability to move the coil through the introducer.The hypo-tube kinking and coil stretching were not originally reported in the complaint.Such damages 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, and no non-conformances related to the reported complaint condition were identified.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points along the manufacturing process to prevent device damages from leaving the facility.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: ¿ 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.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.

• Brand Name: OG TDL CMPLX FRAME COIL 9X30
• 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: 19359924
• Report Number: 3008114965-2024-00508
• Device Sequence Number: 6500193
• Product Code: KRD
• UDI-Device Identifier: 10886704030461
• UDI-Public: 10886704030461
• 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): 05/21/2024

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: 640CR0930
• Device Lot Number: 31053583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2023
• 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: PROLWER SELECT 14 MICROCATHETER
• Patient Sex: Unknown