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

Model Number	640CF0410
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization, a 4x10 orbit galaxy coil (640cf0410, 30679270) was used as the first coil.The physician decided to pull it out for re-deployment after trying another size of coil first.Because the coil's size was not appropriate for the aneurysm.During resheathing the coil, the introducer failed to be re-zipped.The physician used a same like product.The procedure was successfully finished.No additional information is available.There was no patient injury reported.Based on the product analysis of the device received, the embolic coil was found kinked inside of the introducer.
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 was found kinked inside of the introducer.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: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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: complaint conclusion: as reported by the field, during a coil embolization, a 4x10 orbit galaxy coil (640cf0410, 30679270) was used as the first coil.The physician decided to pull it out for re-deployment after trying another size of coil first.Because the coil's size was not appropriate for the aneurysm.During resheathing the coil, the introducer failed to be re-zipped.The physician used a same like product.The procedure was successfully finished.No additional information is available.There was no patient injury reported.A non-sterile og tdl cmplx fill coil 4x10 was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was observed that the gripper was protruding from the introducer.Under microscopic magnification, it was noted that the embolic coil is kinked inside of the introducer and it remains attached to the rest of the device.Also, the introducer component was inspected, and it was found opened by a kinked condition at the point where the gripper is protruding.The damages found on the introducer prevented it from being re-zipped during the functional test and could be related to the issue reported since this damage prevented the zipper from advancing past the kink present on the introducer.The customer complaint was confirmed based on this finding.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 kinked condition of the embolic coil was not originally reported in the complaint and is not related to the reported issue.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.With the limited information available, the root cause of coil kinking remains unknown.It is possible that a continuous flush had not been done, without an adequate flush, issues such as resistance between the coil and the introducer can arise, which may cause some force to be inadvertently exerted on the device, which can result in the coil becoming stretched.However, this cannot be conclusively determined.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) do contain the following recommendation: 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.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 FILL 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15639020
• Report Number: 3008114965-2022-00678
• Device Sequence Number: 17771867
• Product Code: KRD
• UDI-Device Identifier: 10886704030263
• UDI-Public: 10886704030263
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Type of Report: Initial
• Report Date (Section B): 10/20/2022

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: 640CF0410
• Device Catalogue Number: 640CF0410
• Device Lot Number: 30679270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2021
• 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
• Patient Sex: Unknown