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

Catalog Number	GLY120620
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
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 noted to being stretched, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Phone number: (b)(6).Manufacturing site name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).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 a healthcare professional, during a coil embolization of an aneurysm at the ic-pc.The complaint product was attempted to be inserted into a microcatheter (mc) but the coil came out from the catheter.The complaint coil was replaced with another same sized coil and the procedure completed.The customer states there is no additional information available.A non-sterile unit galaxy g3 6mm x 20cm was received inside of a pouch.The hub was inspected, and no damages was noted on it.The dpu was inspected and it was found kinked at 43 cm and 83 cm.Also, the marker band was found at 55 cm from hub, and it was found within specification.The re-sheathing tool was inspected, and it was found in good normal conditions.The introducer was inspected, and it was found in good normal conditions.The v-notch was inspected under microscope and it was found in normal good condition.The rh was inspected under microscope and it was found in good normal conditions.As well as was found no heated.The embolic coil was inspected under microscope and it was found partially protruded of the introducer with a stretch condition.A manufacturing record evaluation was performed for the finished device l11679 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil introducer - prescore rupture¿ was confirmed, since during the visual inspection it was noted that the embolic coil is protruded from introducer.The kinked condition observed on the dpu and the stretch condition noted on the embolic coil might have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.Neither the analysis nor the mre suggest that the failure reported by the costumer could be related to the manufacturing process.Based on the information provided, 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.The instructions for use (ifu) instructs the user to unsheathe a small length of the dpu to unlock the device, then to advance the embolic coil into the microcatheter until the hub connector of the dpu reaches the proximal end of the resheathing tool.This results in the placement of the embolic coil and the more flexible and fragile distal sections of the dpu inside the microcatheter before continuing to unsheathe the device.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 or Problem Description
As reported by a healthcare professional, during a coil embolization of an aneurysm at the ic-pc.The complaint product was attempted to be inserted into a microcatheter (mc) but the coil came out from the catheter.The complaint coil was replaced with another same sized coil and the procedure completed.The customer states there is no additional information available.Based on the product analysis, the embolic coil was noted to being stretched.

• 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
• MDR Report Key: 9146547
• Report Number: 3008114965-2019-01186
• Device Sequence Number: 2623517
• Product Code: KRD
• UDI-Device Identifier: 10886704077541
• UDI-Public: 10886704077541
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/06/2019

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: 02/28/2021
• Device Catalogue Number: GLY120620
• Device Lot Number: L11679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1