MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 4X10; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX0410
Medical Device Problem Codes	Failure to Advance (2524); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No:(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The initial reporter phone: (b)(6).The initial reporter email address was not reported / available.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.A review of manufacturing documentation associated with this lot (30522110) 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 or Problem Description
The healthcare professional reported that during an endovascular embolization procedure, the 4mm x 10cm orbit galaxy complex xtrasoft coil (640cx0410 / 30522110) was impeded in the concomitant microcatheter (unspecified brand).The physician retracted the devices and observed that the delivery wire of the complaint coil was deformed.The guiding catheter, a 6f, 100 cm envoy® guiding catheter (67025800 / 30461480) was observed kinked.The physician replaced the coil and the guiding catheter to complete the procedure.There was no report of any patient adverse event or complication.On 20-jan-2022, additional information was received.The information indicated that the target vessel was the internal carotid artery (ica).Information related to the concomitant microcatheter used was not available.There was an adequate and continuous flush maintained through the microcatheter.No visible kinks nor other damages were observed on the microcatheter.The microcatheter was removed with the coil; the additional information indicated that the delivery wire was deformed.The reported event did not result in a clinically significant delay in the procedure.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received by cerenovus product analysis lab on 12-feb-2022.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during an endovascular embolization procedure, the 4mm x 10cm orbit galaxy complex xtrasoft coil (640cx0410 / 30522110) was impeded in the concomitant microcatheter (unspecified brand).The physician retracted the devices and observed that the delivery wire of the complaint coil was deformed.The guiding catheter, a 6f, 100 cm envoy® guiding catheter (67025800 / 30461480) was observed kinked.The physician replaced the coil and the guiding catheter to complete the procedure.There was no report of any patient adverse event or complication.On 20-jan-2022, additional information was received.The information indicated that the target vessel was the internal carotid artery (ica).Information related to the concomitant microcatheter used was not available.There was an adequate and continuous flush maintained through the microcatheter.No visible kinks nor other damages were observed on the microcatheter.The microcatheter was removed with the coil; the additional information indicated that the delivery wire was deformed.The reported event did not result in a clinically significant delay in the procedure.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 4mm x 10cm orbit galaxy complex xtrasoft coil was received contained in a pouch.Visual inspection was performed.It was noted that the embolic coil component was missing.There was no other damage observed.Microscopic inspection was performed.Under magnification, it was noted that the gripper was observed in stretched condition.This is consistent with the damage reported in the complaint that when the physician retracted the devices, the delivery wire of the complaint coil was deformed.Although functional evaluation could not be performed because the embolic coil component was not returned, the customer complaint was confirmed based on the stretched condition noted on the gripper; this finding could be due to the manipulation required to remove the embolic coil from the concomitant microcatheter.However, the concomitant microcatheter was not returned, therefore, no further evaluation could be performed.A review of manufacturing documentation associated with this lot (30522110) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances 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.It should be noted that product failure is multifactorial.The instructions for use do contain the following precaution: ¿ 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.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.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.

• Brand Name: OG CMPLX XTRASOFT COIL 4X10
• 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): 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 ; 949789-8687
• MDR Report Key: 13335472
• Report Number: 3008114965-2022-00019
• Device Sequence Number: 1646524
• Product Code: KRD
• UDI-Device Identifier: 10886704030645
• UDI-Public: 10886704030645
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/21/2022

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: 01/31/2023
• Device Model Number: 640CX0410
• Device Catalogue Number: 640CX0410
• Device Lot Number: 30522110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 02/12/2022; 03/18/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 02/14/2022; 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2021
• 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: ENVOY 6F, MPD 100CM.
• Patient Sex: Unknown