MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FILL COIL 7X21; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CF0721
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization to the internal carotid parent artery, the physician started to fill an aneurysm with an orbit galaxy 7x21 coil as the first coil, however, it was difficult to position the coil in target site.The coil did not conform to the walls of the aneurysm.The physician withdrew the coil into an unspecified microcatheter (mc) and tried to fill the aneurysm again, but the same issue occurred.Then, the coil was retracted and switched to a new coil to complete the surgery.The microcatheter was not replaced.The procedure was prolonged about 10 minutes.There was no patient injury reported.Additional information received on 08-nov-2023 indicated that the coil did not appear to be damage while in the aneurysm which may have contributed to the positioning difficulty.There were no aneurysm characteristics that may have contributed to the positioning difficulty.The 10-minute surgery prolongation was not clinically significant.
Additional Manufacturer Narrative
Product complaint # (b)(4).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).Section h3 - 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.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).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).Updated sections on this medwatch: b4, g3, g6, h2, h3, h6 and h10.Complaint conclusion: as reported by the field, during a coil embolization to the internal carotid parent artery, the physician started to fill an aneurysm with an orbit galaxy 7x21 coil as the first coil, however, it was difficult to position the coil in target site.The coil did not conform to the walls of the aneurysm.The physician withdrew the coil into an unspecified microcatheter (mc) and tried to fill the aneurysm again, but the same issue occurred.Then, the coil was retracted and switched to a new coil to complete the surgery.The microcatheter was not replaced.The procedure was prolonged about 10 minutes.There was no patient injury reported.Additional information received on 08-nov-2023 indicated that the coil did not appear to be damage while in the aneurysm which may have contributed to the positioning difficulty.There were no aneurysm characteristics that may have contributed to the positioning difficulty.The 10-minute surgery prolongation was not clinically significant.A non-sterile orbit galaxy 7x21 was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and no abnormalities were found (i.E., no kinks, or bents).Under microscopic magnification, it was noted that the embolic coil is in good condition (i.E., no stretched, no elongations) and this remains attached to the gripper.The issue regarding a coil poor conformability could not be evaluated since the reported issue is specific to the patient and procedure at the time of occurrence and cannot be replicated in the laboratory.However, positioning difficulty is a known potential issue associated with the use of the device.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.A manufacturing record evaluation was performed for the finished device 31039307 number, and no non-conformances related to the malfunction were identified.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Since no device deficiency was found, no capa activity is required.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) do contain the following recommendation: ¿ appropriate selection of the detachable coil is critical to ensure device effectiveness and patient safety.Examine pre-embolization angiograms in order to choose the optimum device for any given lesion.It is important to select the optimum coil length, coil diameter, and coil type to ensure desired volumetric filling.As part of the 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 damages such as coil kinking 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 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 7X21
• 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: 18092176
• Report Number: 3008114965-2023-00815
• Device Sequence Number: 6254320
• Product Code: KRD
• UDI-Device Identifier: 10886704030362
• UDI-Public: 10886704030362
• 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): 01/09/2024

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: 02/28/2025
• Device Catalogue Number: 640CF0721
• Device Lot Number: 31039307
• 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: 10/23/2023
• Supplement Date Received by Manufacturer: 12/04/2023; 12/28/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 12/12/2023; 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• 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: UNSPECIFIED MICROCATHETER
• Patient Sex: Unknown