MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 6MM X 15CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLY120615
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2020
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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device l12528 number, and no non-conformances related to the reported complaint condition were identified.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization, a 6mm x 15cm galaxy g3 coil (gly120615, l12528) was being used as a second coil but it became stuck on the sheath introducer when the coil was pushed from the sheath introducer.The complaint coil was inserted into a concomitant microcatheter (sl10, stryker), however, the complaint coil got stuck on the microcatheter and it became unraveled.It was replaced with another coil and the procedure completed.There was no report of patient injury.The customer states there is no additional information available.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Section b5: additional information was received indicating that no excessive force was applied to the device.Adequate flush had been maintained through the devices.The customer states there is no additional information available.Section e1: initial reporter phone: (b)(6).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, a 6mm x 15cm galaxy g3 coil (gly120615, l12528) was being used as a second coil but it became stuck on the sheath introducer when the coil was pushed from the sheath introducer.The complaint coil was inserted into a concomitant microcatheter (sl10, stryker), however, the complaint coil got stuck on the microcatheter and it became unraveled.It was replaced with another coil and the procedure was completed.There was no report of patient injury.Additional information was received indicating that no excessive force was applied to the device.Adequate flush had been maintained through the devices.The customer states there is no additional information available.The device was not returned for analysis therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device l12528 number, and no non-conformances related to the reported complaint condition were identified.With the information available and without the product available for analysis, the reported customer complaints of ¿detachable coil delivery system (dcs) - impeded in microcatheter with no loss of cerebral target position¿ and ¿oil - unraveled/stretched-in microcatheter¿ 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 instructions for use (ifu) warns that if the microcoil system becomes immobile in the infusion microcatheter, apply a gentle push-pull motion to free it.If unsuccessful, remove both microcatheter and microcoil system together as a unit and replace with new devices.Assignment of root cause for the events remains speculative and inconclusive, based on the limited information provided and without the return of the complaint devices; however, it is possible that procedural and handling factors, including device manipulation, insufficient flush, and interaction with the concomitant microcatheter, may have contributed to the reported failures.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: GALAXY G3 6MM X 15CM
• 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: 9811018
• Report Number: 3008114965-2020-00058
• Device Sequence Number: 3002886
• Product Code: KRD
• UDI-Device Identifier: 10886704077534
• UDI-Public: 10886704077534
• 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,Followup
• Report Date (Section B): 02/21/2020

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: 04/30/2021
• Device Model Number: GLY120615
• Device Catalogue Number: GLY120615
• Device Lot Number: L12528
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL10 MICROCATHETER, STRYKER