MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FILL COIL 5X15; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CF0515
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization, the physician tried to deploy a 6x20 orbit galaxy coil (640cr0620, 30558303) through an sl10 microcatheter (mc).While deploying, the physician encountered resistance midway through the catheter.The physician tried to advance unspecified coils but faced resistance.Then, the doctor tried to deploy a 5x15 orbit galaxy (640cf0515, 30668570) as well but experienced similar resistance midway through the mc.The doctor removed both coils and deployed stryker coils through the same microcatheter and finished the case.There were no procedural delays due to the event.The procedure was successfully completed.Additional information received indicated that the device did not appear to be damaged at any time.Nothing was noted to be obstructing the microcatheter.Based on the product analysis of the 5x15 orbit galaxy (640cf0515, 30668570) received, the embolic coil has a kinked condition on its distal end, and it was noted that is broken.
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The embolic coil has a kinked condition on its distal end, and it was noted that is broken.The findings meet us regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.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.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.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 a coil embolization, the physician tried to deploy a 6x20 orbit galaxy coil (640cr0620, 30558303) through an sl10 microcatheter (mc).While deploying, the physician encountered resistance midway through the catheter.The physician tried to advance unspecified coils but faced resistance.Then, the doctor tried to deploy a 5x15 orbit galaxy (640cf0515, 30668570) as well but experienced similar resistance midway through the mc.The doctor removed both coils and deployed stryker coils through the same microcatheter and finished the case.There were no procedural delays due to the event.The procedure was successfully completed.Additional information received indicated that the device did not appear to be damaged at any time.Nothing was noted to be obstructing the microcatheter.A non-sterile og tdl cmplx fill coil 5x15 was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and no apparent damage was observed.The device was inspected under microscopic magnification, and it was found that the embolic coil has a kinked condition on its distal end, and it was noted that is broken.It remains inside the introducer.The conditions in which the coil was found preclude the proper testing of the device.Even with this, the customer complaint was confirmed since the coil could not move.A manufacturing record evaluation was performed for the finished device, and no non-conformances related to the reported complaint condition were identified.Coil kinking is a known potential issue associated with the use of this device.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.Kinking can occur during procedure handling where force may have been inadvertently applied.The complaint documented that the coil could not be advanced through the midway from the concomitant microcatheter; the complaint coil was removed from the patient.It is possible that force may have inadvertently been applied during the coil advancement in an attempt to overcome the resistance, which resulted in the coil kinking.The severity of the kinked conditions in the coil results in the broken condition found.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) do contain the following recommendations: 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 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.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 FILL COIL 5X15
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15679457
• Report Number: 3008114965-2022-00686
• Device Sequence Number: 5960828
• Product Code: KRD
• UDI-Device Identifier: 10886704030300
• UDI-Public: 10886704030300
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2022

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: 640CF0515
• Device Catalogue Number: 640CF0515
• Device Lot Number: 30668570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2021
• 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 6X20; SL10 MICROCATHETER
• Patient Sex: Unknown