MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FRAME COIL 8X30; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CR0830
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.The product lot number was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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 coil embolization, an 8x30 orbit galaxy (640cr0830, lot unknown) detached into the unspecified microcatheter (mc).The surgery was delayed due to the reported event by 20 minutes.Another microcatheter was used with another coil.The procedure was successfully completed.No fragments were generated.There were no patient consequences.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complaint conclusion: as reported by the field, during an intracranial coil embolization, an 8x30 orbit galaxy (640cr0830, lot unknown) detached into the unspecified microcatheter (mc).The surgery was delayed due to the reported event by 20 minutes.Another microcatheter was used with another coil.The procedure was successfully completed.No fragments were generated.There were no patient consequences.No additional information is available.The device has discarded; therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.With the information available and without the product available for analysis, the reported customer complaint of ¿coil ¿ premature detachment in microcatheter¿ could not be confirmed.Premature detachment is the microcatheter is a known potential procedural complication associated with the galaxy g3 coil.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, vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.Excessive force applied to a coil through repeated coil deployments or manipulation can increase the possibility of stretching and premature detachment.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).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 coil embolization, an 8x30 orbit galaxy (640cr0830, lot unknown) detached into the unspecified microcatheter (mc).The surgery was delayed due to the reported event by 20 minutes.Another microcatheter was used with another coil.The procedure was successfully completed.No fragments were generated.There were no patient consequences.No additional information is available.A non-sterile unit og tdl cmplx frame coil 8x30 was returned to cerenovus for evaluation.Cerenovus conducted a visual inspection and microscopic inspection.During the visual analysis of the device, the hypo-tube was found kinked.Procedural factors may have contributed to the finding; however, based on the information currently available, this cannot be conclusively determined.This finding is not related to the customer complaint.During the microscopic inspection, it was found that the embolic coil is still attached to the rest of the device in good normal conditions.As a result, a follow-up was performed to gain clarification, no further information is available.The lot number is not known; therefore, a device history record review cannot be completed.Since no damages were observed on the embolic coil, the customer complaint regarding coil.Premature detachment-in microcatheter could not be confirmed.The lot number was not provided, as a result, a manufacturing record evaluation could not be performed.Premature detachment is a known potential occurrence with use of this device.It should be noted that product failure is multifactorial.The instructions for use (ifu) does contain the following precaution: ¿ do not exceed the red line beyond position 1 during any part of the purging operation.Excess pressure during preparation could lead to detachment of the coil during the purging operation.If the red line beyond position 1 is exceeded at any point during preparation, visually inspect the detachable coil to confirm coil attachment.Assignment of root cause for the event 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 failure.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.
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.

• Brand Name: OG TDL CMPLX FRAME COIL 8X30
• 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: 11913217
• Report Number: 3008114965-2021-00220
• Device Sequence Number: 4417487
• Product Code: KRD
• UDI-Device Identifier: 10886704030454
• UDI-Public: 10886704030454
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/08/2021

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
• Operator of Device: Health Professional
• Device Model Number: 640CR0830
• Device Catalogue Number: 640CR0830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 06/01/2021; 11/19/2021; 12/07/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 06/21/2021; 12/07/2021; 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Male
• Patient Weight: 65 KG