MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FILL COIL 4X12; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number 640CF0412

Device Problem Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2023

Event Type  malfunction  

Manufacturer Narrative

Hold or w.S 07/21.Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was found stretched.The findings meet us regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.A non-sterile og tdl cmplx fill coil 4x12 was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and three (3) kinked conditions were observed along the delivery tube; the first at 67 cm, the second at 119.5 cm, and the third at 161.5 cm.All measurements were taken from the proximal end of the device.The device was inspected under microscopic magnification, and it was found that the embolic coil was severely stretched at the proximal portion, and it remained attached to the rest of the device.The blue fiber was noted to be exposed.No other damages were noted.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The impeded condition of the coil in the microcatheter, as documented in the complaint, could not be tested since the conditions in which the coil was received prevented the advancement and retraction through the introducer.However, such conditions can be reasonably considered secondary to the issue encountered during the procedure.Based on this, the customer complaint was able to be confirmed.Coil stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.Stretching can occur during procedure handling where force may have been inadvertently applied.Such coil conditions were not originally reported in the complaint, and with the limited information available, the root cause of the coil stretching remains unknown.It is possible that a continuous flush had not been done; without an adequate flush, issues such as resistance between the coil and the introducer can arise, which may cause some force to be inadvertently exerted on the device, which can result in the coil becoming stretched and/or the delivery tube become kinked.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent 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 multiple factors could cause product failure.The instructions for use (ifu) do contain the following recommendation: 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.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.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 Description

As reported by the field, during a coil embolization, the physician tried to deploy a 4x12 orbit galaxy coil (640cf0412, 30706301) through an headway microcatheter (mc).However, while advancing the coil through the catheter midway, the physician felt resistance.The doctor was unable to push the coil further.After few tries the user removed the coil and deployed a competitor¿s coil.There was no surgery delays due to the reported event.Based on the product analysis of the device received, the embolic coil was found stretched.

• Brand Name: OG TDL CMPLX FILL COIL 4X12
• Type of Device: 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: 17370990
• MDR Text Key: 319602373
• Report Number: 3008114965-2023-00518
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704030270
• UDI-Public: 10886704030270
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K093973
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 640CF0412
• Device Catalogue Number: 640CF0412
• Device Lot Number: 30706301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEADWAY MICROCATHETER