MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 4MM X 12CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number GLY120412

Device Problems Material Rupture (1546); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2021

Event Type  malfunction  

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 noted as being kinked, meeting regulatory reporting criteria.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).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Complaint conclusion: as reported by the field, upon loading a galaxy g3 4mm x 12cm coil (gly120412, 30490143) the coil came out of the sides.The coil was tested and no visible problem when inserted into the rhv.Additional information received clarified that the issue is reported to have occurred on the attempted introduction into the microcatheter.The coil was not deployed.It is said to have come out of the introduction tool side wall.An adequate continuous flush maintained through the sl10 microcatheter (mc).There was a level of resistance at the level of the rhv.It was not necessary to remove the microcatheter.There was no patient injury reported.There was no significant delay in the procedure due to the event.A non-sterile galaxy g3 4mm x 12cm was received for analysis, also it was received with an sl10 microcatheter (non j&j product) and an rhv.The device was inspected, and it was found that the core wire was kinked at 15 inches from the proximal end.Also, it was noted that the core wire was protruding from the introducer.The introducer was found damaged.No other damages or anomalies were observed.The device was inspected under a microscope, and it was found that the embolic coil is kinked and protruded from the introducer.The functional test could not be performed due to the conditions in which the device was received.A manufacturing record evaluation (mre) was performed for the finished device 30490143 number, and no non-conformances related to the reported complaint condition were identified.Cerenovus conducted a visual and microscopic inspection of the returned device.The functional test could not be performed due to the conditions in which the device was received.The visual inspection of the returned sample determined that the core wire is kinked and protruded from the introducer through the split noted during the visual inspection.The introducer was also found damaged.The protruded condition observed on the device is related to the customer experience at the procedure time regarding ¿coil introducer - prescore rupture¿ and the kinked condition in the core wire are related to the ¿detachable coil delivery system (dcs) - resistance/friction-during advancement with no loss of cerebral target position¿, due to these conditions the customer complaint was confirmed.A microscopic test was performed, and it was found that the embolic is kinked and protruded from the introducer.The conditions above noted could be the result of the believed resistance at the level of the rhv, as reported in the event description.A manufacturing record evaluation was performed, and no non-conformance's related to the reported complaint condition were identified.It should be noted that product failure could be caused by multiple factors.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.If unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw and examine the delivery catheter system.Assignment of root cause for the events 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 failures and damages on the returned system.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.

Event Description

As reported by the field, upon loading a galaxy g3 4mm x 12cm coil ( gly120412, 30490143) the coil came out of the sides.The coil was tested and no visible problem when inserted into the rhv.Additional information received clarified that the issue is reported to have occurred on the attempted introduction into the microcatheter.The coil was not deployed.It is said to have come out of the introduction tool side wall.An adequate continuous flush maintained through the sl10 microcatheter (mc).There was a level of resistance at the level of the rhv.It was not necessary to remove the microcatheter.There was no patient injury reported.There was no significant delay in the procedure due to the event.Based on the product analysis on the device received, the embolic coil is kinked.

• Brand Name: GALAXY G3 4MM X 12CM
• Type of Device: 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13051776
• MDR Text Key: 288497646
• Report Number: 3008114965-2021-00755
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704077480
• UDI-Public: 10886704077480
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K150319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: GLY120412
• Device Catalogue Number: GLY120412
• Device Lot Number: 30490143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SL10 MICROCATHETER