MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 7MM X 21CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLY120721
Medical Device Problem Codes	Separation Failure (2547); Premature Separation (4045)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).(b)(4).[conclusion]: the healthcare professional reported that during the stent-assisted coil embolization procedure of an unruptured aneurysm, after the stent was implanted, the 7mm x 21cm galaxy g3 coil (gly120721 / l12288) was selected as the first framing coil, but the coil failed to detach.The detach button on the control cable was pressed several times, but the issue continued.It was confirmed that all the connections appeared to fit properly without the application of excessive force.The physician attempted to resheath the coil, but it became prematurely detached in the microcatheter.The wire was used to push the prematurely detached coil into the aneurysm.The procedure was concluded with the implantation of competitor coils.There was no report of any patient injury or complication as a result of the reported event.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (l12288) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances 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.Failure to detach and premature detachment are known potential complications associated with the galaxy g3 coil.Based on the minimal information provided, it is not possible to determine the root cause of the detachment issue.It was not reported whether the control cable or detachment control box (dcb) were replaced during the procedure.It is also unknown if a pre-deployment electrical check was performed.Potential root causes of failure to detach include failure to confirm secure connection of the cable to the dpu and dcb.The instructions for use (ifu) advises that if after depressing the detach button on the dcb or control cable, the dcb should be replaced if the light and audible tone do not activate.Also, if a fault light is detected, the system ready light is not illuminated, or there is no detachment after two detachment attempts, the dcb should be replaced.If detachment still does not occur, the microcoil system should be carefully withdrawn and replaced.If the microcoil is positioned at a relative sharp angle to the microcatheter, the coil may stretch or break as it is being withdrawn.By positioning the distal tip of the catheter at or slightly inside the ostium of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.Excessive force applied to a coil through repeated coil deployments or manipulation can increase the possibility of premature detachment.If a coil partially deployed into an aneurysm prematurely detaches while inside of the delivery catheter, that is if the proximal end of the coil remains in the microcatheter, then the device positioning unit (dpu) wire may be still be used to completely deploy the coil into the aneurysm.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided; however, it is possible that procedural and handling factors may have contributed.Since the alleged failure to detach and premature detachment could potentially result in serious injury, they are considered mdr reportable as a malfunction; however, since additional intervention of pushing the coil back into the aneurysm was necessary, the complaints meets mdr reporting criteria as a ¿serious injury.¿ 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.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 stent-assisted coil embolization procedure of an unruptured aneurysm, after the stent was implanted, the 7mm x 21cm galaxy g3 coil (gly120721 / l12288) was selected as the first framing coil, but the coil failed to detach.The detach button on the control cable was pressed several times, but the issue continued.It was confirmed that all the connections appeared to fit properly without the application of excessive force.The physician attempted to resheath the coil, but it became prematurely detached in the microcatheter.The wire was used to push the prematurely detached coil into the aneurysm.The procedure was concluded with the implantation of competitor coils.There was no report of any patient injury or complication as a result of the reported event.

• Brand Name: GALAXY G3 7MM X 21CM
• 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: 8898504
• Report Number: 3008114965-2019-01109
• Device Sequence Number: 1658711
• Product Code: KRD
• UDI-Device Identifier: 10886704077565
• UDI-Public: 10886704077565
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: GLY120721
• Device Lot Number: L12288
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention