MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 6MM X 20CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLY120620
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization, the physician tried to resheath the coil but not possible.The sheath ripped.There were no patient consequences.The device was replaced with a new coil.No additional information is available.Based on the analysis of the device received, the embolic coil was found to be severely stretched.
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 stretched, meeting 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.A non-sterile galaxy g3 6mm x 20cm was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it could be noted that the coil is partially outside of the introducer.Some kinked conditions were noted in the core wire near the point where it was noted protruding from the introducer.The device was inspected under microscopic magnification, and it was found that the introducer was opened at the point where the core wire protrudes; this opened condition was caused by a kinked condition found in the introducer.Also, the embolic coil was inspected, and it was found to be severely stretched; it remains attached to the resistance heating (rh).No other damages were found in the device.The damages noted in the device suggest that it was subjected to excessive force and other factors not described in this complaint.The customer complaint was able to be confirmed since damages found on the introducer prevented it from being re-zipped; this damage prevented the zipper from advancing past the kink present on the introducer resulting in the protruding condition noted in the coil; however, there is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.Coil stretching 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.Stretching can occur during procedure handling where force may have been inadvertently applied.The stretched condition of the embolic coil was not originally reported in the complaint.With the limited information available, the root cause of the coil stretching remains unknown.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device and this condition is not considered a contributing factor to the reported failure.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) does contain the following recommendations: do not fasten the rhv valve too tightly around the introducer sheath since excessive pressure may cause damage to the introducer sheath and/or the microcoil as it is advanced into the infusion microcatheter.Additionally, if the introducer tip and microcatheter hub are misaligned, damage may occur to the microcoil as it passes through this transition.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.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 803 (and/or part 4, as applicable).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.

• Brand Name: GALAXY G3 6MM X 20CM
• 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. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16232733
• Report Number: 3008114965-2023-00068
• Device Sequence Number: 17885525
• Product Code: KRD
• UDI-Device Identifier: 10886704077541
• UDI-Public: 10886704077541
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K150319
• 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): 01/24/2023

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: 12/31/2024
• Device Model Number: GLY120620
• Device Catalogue Number: GLY120620
• Device Lot Number: 30719535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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