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

Model Number	640CR0620
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient height, race, and ethnicity was not reported.Procode: krd/hcg.(b)(6).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 supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr 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 an intracranial procedure, a og tdl cmplx frame coil 6x20 (640cr0620, 30451950) detached in the unspecified microcatheter (mc).The procedure was successfully completed with another coil and microcatheter.No additional information was provide at the time of complaint entry.
Additional Manufacturer Narrative
Product complaint #: (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during an intracranial procedure, a og tdl cmplx frame coil 6x20 (640cr0620, 30451950) detached in the unspecified microcatheter (mc).The procedure was successfully completed with another coil and microcatheter.No additional information is available.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device 30451950 number, and no non-conformances related to the reported complaint condition were identified.With the information available and without the product available for analysis, the reported customer complaint of ¿coil ¿ premature detachment¿ could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the event is related to the device manufacturing process.Premature detachment in microcatheter is a known potential procedural complication associated with the orbit galaxy neurovascular embolization device.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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.
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) a supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion updated with product analysis: as reported by the field, during an intracranial procedure, an og tdl cmplx frame coil 6x20 (640cr0620, 30451950) detached in the unspecified microcatheter (mc).The procedure was successfully completed with another coil and microcatheter.No additional information is available.A non-sterile og tdl cmplx frame coil 6x20 was received coiled inside of a pouch.The device was inspected, the hypo-tube was found severely kinked.No other damages or anomalies were observed on the rest of the device.The device was inspected under a microscope, and it was found that the coil was not attached to the device, and due to this, it was not able to be evaluated.A manufacturing record evaluation (mre) was performed for the finished device 30451950 number, and no non-conformances related to the reported complaint condition were identified.The product was returned to cerenovus for evaluation.Visual inspection and microscopic analysis were conducted on the returned device.Visual analysis of the returned og tdl cmplx fill coil 6x20 microcatheter revealed that the hypo-tube was found severely kinked.No other damages or anomalies were observed on the rest of the device.The microscopic analysis of the returned sample determined that the coil was already detached from the device, due to this condition the customer complaint ¿coil- premature detachment-in microcatheter¿ was confirmed.However, the exact time when the detachment process occurred could not be conclusively determined.There is no evidence of mechanical detachment or stress that suggests excessive force applied, however, there are procedural and other factors that may have contributed to the failure.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.Although no conclusion could be reached on the cause of the reported event, the instructions for use (ifu) does 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.¿ repositioning the infusion catheter while the coil is deployed can lead to damage and/or premature detachment of the coil.Assignment of root cause for the events remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failures and damages on the returned system.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 cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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.

• Brand Name: OG TDL CMPLX FRAME 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): 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 ; 9497898687
• MDR Report Key: 11877241
• Report Number: 3008114965-2021-00217
• Device Sequence Number: 1099438
• Product Code: KRD
• UDI-Device Identifier: 10886704030430
• UDI-Public: 10886704030430
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/13/2022

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: 08/31/2022
• Device Model Number: 640CR0620
• Device Catalogue Number: 640CR0620
• Device Lot Number: 30451950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2021
• Supplement Date Received by Manufacturer: 06/23/2021; 11/19/2021; 01/05/2022
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 07/13/2021; 12/07/2021; 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2020
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 68 KG