MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FILL COIL 6X20; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CF0620
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).Section d2b ¿ procode: krd/hcg a non-sterile 6mm x 20mm orbit galaxy complex frame coil was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and a broken condition was found in the hypo-tube.The coil was returned inside the introducer.The device was inspected under microscopic magnification, and it was found that the embolic coil was attached to the delivery system, and no damages were found on it (i.E., no elongations, kinks, or non-concentric loops were noted).The issues regarding resistance felt while pushing was confirmed based on the findings mentioned above.The broken condition appearance of the returned device suggests that it was subjected to excessive force to overcome the friction with the microcatheter.Factors not described in the event description, such as inadequate flush, may have contributed to the issue encountered during the procedure.According to the risk documentation, resistance in microcatheter is a potential issue that can occur during microcoil placement due to excessively tortuous anatomy, which can result in the hypo-tube being broken.There is no indication that the issue reported is a result of a defect inherently related to the device.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Therefore, no capa activity is required.A manufacturing record evaluation was performed for the finished device 30862483 number, and no non-conformances related to the malfunction were identified.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) contain the following precautions: never advance, withdraw, or torque the delivery tube against resistance without first determining the cause of resistance under fluoroscopy.Manipulation of the delivery tube against resistance can cause damage and/or premature detachment of the coil.If friction is noted with any subsequent detachable coil system, carefully examine the detachable coil system and the infusion catheter for possible damage.Replace both if necessary.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.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 an internal carotid artery (ica) supraclinoid aneurysm, there was resistance while pushing an orbit galaxy coil (640cf0620, 30862483) onto a prowler select lpes microcatheter (606s155x, 31178991).The surgery was delayed by 15 minutes due to the event.Additional event information received on 01-apr-2024 indicated that the 15 minutes delay was considered to be not clinically significant.The resistance was first felt at the mid shaft of the microcatheter.It was not necessary to remove or replace the microcatheter.The device did not appear damaged.Nothing was noted to be obstructing the microcatheter (mc).A continuous flush on the microcatheter was maintained.Based on the product analysis of the orbit galaxy coil (640cf0620, 30862483), the delivery tube (hypo tube) - broken was found broken.

• Brand Name: OG TDL CMPLX FILL COIL 6X20
• 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: 19222235
• Report Number: 3008114965-2024-00462
• Device Sequence Number: 6961138
• Product Code: KRD
• UDI-Device Identifier: 10886704030348
• UDI-Public: 10886704030348
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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: 05/31/2024
• Device Catalogue Number: 640CF0620
• Device Lot Number: 30862483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• 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