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

Model Number 640CR0620

Device Problem Difficult to Advance (2920)

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

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Procode is krd/hcg.The initial reporter phone and email address are not available / reported.[conclusion]: the healthcare professional reported that during an endovascular embolization procedure, there was resistance during the advancement of the 6mm x 20cm orbit galaxy complex frame coil (640cr0620 / 30383959) through the concomitant echelon¿ 10 microcatheter (medtronic); the resistance was in the mid-shaft of the microcatheter.Continuous flush was maintained through the microcatheter.It was reported that nothing was obstructing the microcatheter, the introducer was flushed and firmly installed onto the hub of the microcatheter and locked with the rotating hemostasis valve (rhv) during the device advancement.Other orbit galaxy coils were successfully used with the microcatheter prior to the reported issue.The 6mm x 20cm orbit galaxy complex frame coil was successfully removed from the concomitant microcatheter without the microcatheter removed from the target position.No damage was noted on the complaint coil.The coil was replaced.The event resulted in a 10-minute procedure delay but the procedure was successfully completed.There was no report of any patient adverse event or complication.The device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 6mm x 20cm orbit galaxy complex frame coil was received contained in a pouch.Visual inspection was performed.It was observed that the embolic coil component is entangled with the rest of the device.The introducer was not returned for evaluation.No other damages nor anomalies were observed during the visual inspection.Microscopic inspection was performed.Under magnification, the embolic coil component was confirmed to be in stretched condition and is entangled with the rest of the device.Functional test could not be performed due to the condition noted in the visual and microscopic inspection.A review of manufacturing documentation associated with this lot (30383959) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformance's related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The complaint documented that during the procedure, there was resistance during the advancement of the 6mm x 20cm orbit galaxy complex frame coil through the concomitant echelon¿ 10 microcatheter (medtronic); the resistance was in the mid-shaft of the microcatheter.Continuous flush was maintained through the microcatheter.The complaint device was returned without the introducer.Under magnification, the embolic coil is observed in stretched condition and entangled with the rest of the device, which precluded the functional testing for the reported issue related to the resistance / friction encountered when the coil was in the mid-shaft of the microcatheter.It was reported that nothing was obstructing the microcatheter, but the embolic coil component was in stretched condition and entangled with the rest of the device.These observed conditions may have occurred during post-procedure handling and/or during shipping of the device.However, based on these observation, the issue reported is confirmed with the exact cause not being conclusively determined, it is possible that procedure factors such as device interaction and device manipulation may have been the contributed to the stretched and entangled condition of the embolic coil component.It should be noted that product failure is multifactorial.The instructions for use (ifu) does 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 unusual friction is noted within the infusion catheter, remove the detachable coil system.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.Coil stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issue from occurring.Stretching can occur during procedure handling where force may have been inadvertently applied.The stretched condition of the embolic coil was not originally reported in the complaint.The exact cause of the stretched condition of the coil cannot be conclusively determined; however, it is possible that during the attempt to advance the coil when resistance was encountered at the mid-shaft of the catheter, some force was inadvertently applied to the device which resulted in the coil becoming stretched and ultimately the stretched coil becoming entangled with the rest of the device.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 6mm x 20cm orbit galaxy complex frame coil left the manufacturing facility with the embolic coil in stretched condition and entangled with the device.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that during an endovascular embolization procedure, there was resistance during the advancement of the 6mm x 20cm orbit galaxy complex frame coil (640cr0620 / 30383959) through the concomitant echelon¿ 10 microcatheter (medtronic); the resistance was in the mid-shaft of the microcatheter.Continuous flush was maintained through the microcatheter.It was reported that nothing was obstructing the microcatheter, the introducer was flushed and firmly installed onto the hub of the microcatheter and locked with the rotating hemostasis valve (rhv) during the device advancement.Other orbit galaxy coils were successfully used with the microcatheter prior to the reported issue.The 6mm x 20cm orbit galaxy complex frame coil was successfully removed from the concomitant microcatheter without the microcatheter removed from the target position.No damage was noted on the complaint coil.The coil was replaced.The event resulted in a 10-minute procedure delay but the procedure was successfully completed.There was no report of any patient adverse event or complication.The complaint devices were returned for evaluation and analysis.During the microscopic inspection of the 10mm x 30cm orbit galaxy complex fill coil (640cr0620 / 30383959), the embolic coil was observed to be stretched and entangled with the rest of the device.Based on the product analysis on 15 dec 2021, this event has been deemed mdr reportable as a ¿malfunction.¿.

• Brand Name: OG TDL CMPLX FRAME COIL 6X20
• 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): CODMAN & SHURTLEFF, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 13014425
• MDR Text Key: 289746376
• Report Number: 3008114965-2021-00681
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704030430
• UDI-Public: 10886704030430
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2021

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: 02/28/2022
• Device Model Number: 640CR0620
• Device Catalogue Number: 640CR0620
• Device Lot Number: 30383959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2020
• 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: ECHELON¿ 10 MICROCATHETER (MEDTRONIC); OG TDL CMPLX FRAME COIL 7X25