MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 8MM X 24CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLY120824
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.(b)(6).The email address of the initial reporter is not available / reported.(b)(4).[conclusion]: the healthcare professional reported that during the coil embolization procedure of a dural arteriovenous fistula (davf), after four coils were use, the 8mm x 24cm galaxy g3 coil (gly120824 / l12142) was chosen as the fifth coil.The galaxy g3 coil was inserted into the sheath introducer but the coil prematurely detached from the slit.The coil was removed and replaced.The procedure was completed without any reported patient injury or complication.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot l12142 presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined; however, it is possible that circumstances of the procedure and/or device manipulation/interaction may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.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.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during the coil embolization procedure of a dural arteriovenous fistula (davf), after four coils were use, the 8mm x 24cm galaxy g3 coil (gly120824 / l12142) was chosen as the fifth coil.The galaxy g3 coil was inserted into the sheath introducer but the coil prematurely detached from the slit.The coil was removed and replaced.The procedure was completed without any reported patient injury or complication.

• Brand Name: GALAXY G3 8MM X 24CM
• 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: 9234115
• Report Number: 3008114965-2019-01198
• Device Sequence Number: 14074509
• Product Code: KRD
• UDI-Device Identifier: 10886704077589
• UDI-Public: 10886704077589
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2019

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: 03/31/2021
• Device Catalogue Number: GLY120824
• Device Lot Number: L12142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1