MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 2.5MM X 2.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX122525
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2020
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.The initial reporter phone: (b)(6).The initial reporter email address is not available / reported.[conclusion]: the healthcare professional reported that during the coil embolization targeting an unruptured aneurysm, three g3 coils were used.The 2.5mm x 2.5cm galaxy g3 xsft coil (glx122525 / l13191) was the fourth coil chosen to be used, but it unraveled.Continuous flush had been maintained through the microcatheter.The coil was not detached.There was no blood flow restriction or reduction as a result of the issue reported.The event did not cause any clinically significant delay.There is no report of any patient adverse event 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 (l13191) 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.Coil unraveling / stretching is a known potential issue associated with the use of this device.The instruction for use (ifu) provides proper handling instructions for the device to prevent such issue from occurring.The embolic coil can become unraveled or stretched during attempts to withdrawal it against resistance.It can also unravel or stretch if there was excessive force applied / exerted on it during procedural handling.Interaction with concomitant device(s) may also result in the coil becoming unraveled / stretched.With the limited information available and without the embolic coil and the concomitant microcatheter 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.Assignment of root cause for the event remains speculative and inconclusive.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 targeting an unruptured aneurysm, three g3 coils were used.The 2.5mm x 2.5cm galaxy g3 xsft coil (glx122525 / l13191) was the fourth coil chosen to be used, but it unraveled.Continuous flush had been maintained through the microcatheter.The coil was not detached.There was no blood flow restriction or reduction as a result of the issue reported.The event did not cause any clinically significant delay.There is no report of any patient adverse event or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 9/24/2020.[additional event information]: the sales representative provided additional information that indicated that the 2.5mm x 2.5cm galaxy g3 xsft coil did unravel as reported, but the coil unraveled inside the concomitant microcatheter (brand unknown).It was also reported that the physician tried another competitive coil (brand unknown) in the same situation and encountered the same issue with the coil becoming unraveled.The physician thinks the issue is caused by a malfunction in of the competitive microcatheter.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.

• Brand Name: GALAXY G3 XSFT 2.5MM X 2.5CM
• 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: 10473411
• Report Number: 3008114965-2020-00358
• Device Sequence Number: 14187680
• Product Code: KRD
• UDI-Device Identifier: 10886704077602
• UDI-Public: 10886704077602
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2020

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: 06/30/2021
• Device Model Number: GLX122525
• Device Catalogue Number: GLX122525
• Device Lot Number: L13191
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1