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

Model Number	640CR0830
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization at the middle cerebral artery , an 8x30 orbit galaxy coil (640cr0830, 30666505) became impeded in an echelon-10,45°tip microcatheter (mc).The mc could not advance any more.The physician switched to a 7x25 orbit galaxy coil (640cr0725, 30628880) but the same issue occurred.The microcatheter was replaced and the same problem remained.Then a new competitor device was used to complete the surgery.There was no patient injury reported.It is unknown if there appeared to be any damage to the devices at any time.It is unknown if there was anything obstructing the microcatheter.
Additional Manufacturer Narrative
Product complaint # (b)(4).Procode: krd/hcg.Initial reporter phone: (b)(6).Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2022-00418 and 3008114965-2022-00419.
Additional Manufacturer Narrative
Product complaint # (b)(4).Section b5: additional information received indicated that the devices did not appear damaged at any time.There was nothing noted to be obstructing the microcatheter.Complaint conclusion: as reported by the field, during a coil embolization at the middle cerebral artery, an 8x30 orbit galaxy coil (640cr0830, 30666505) became impeded in an echelon-10,45°tip microcatheter (mc).The mc could not advance anymore.The physician switched to a 7x25 orbit galaxy coil (640cr0725, 30628880) but the same issue occurred.The microcatheter was replaced and the same problem remained.Then a new competitor device was used to complete the surgery.There was no patient injury reported.It is unknown if there appeared to be any damage to the devices at any time.It is unknown if there was anything obstructing the microcatheter.Additional information received indicated that the devices did not appear damaged at any time.There was nothing noted to be obstructing the microcatheter.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30666505 number, and no non-conformances related to the malfunction were identified.Impeded in microcatheter is a known potential product failure associated with the use of the device.The instructions for use (ifu) includes warnings and instructions for use to trouble shoot this type of situation.The ifu warns that if the microcoil system becomes immobile in the infusion microcatheter, apply a gentle push-pull motion to free it.If unsuccessful, remove both microcatheter and microcoil system together as a unit and replace with new devices.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the event is related to the device manufacturing process.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.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.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14675966
• Report Number: 3008114965-2022-00418
• Device Sequence Number: 4818007
• Product Code: KRD
• UDI-Device Identifier: 10886704030454
• UDI-Public: 10886704030454
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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: 09/30/2023
• Device Model Number: 640CR0830
• Device Catalogue Number: 640CR0830
• Device Lot Number: 30666505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2021
• 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: OG TDL CMPLX FRAME COIL 7X25
• Patient Sex: Unknown