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	04/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.This is one of three products involved with the complaint and the associated manufacturer report numbers are: 3008114965-2020-00144 and 3008114965-2020-00145.Complaint conclusion: as reported by a healthcare professional, during an intracranial coil embolization, two a 4x5mm micrusframe coils were used successfully as the first and second coils with a headway 17 microcatheter (mc).However, a 6mm x 15cm galaxy g3 coil (gly120615, l16321), a 6mm x 11.9cm micrusframe10 coil (mfr100611, l10198) and a 6mm x 26cm micrusframe10 coil (mfr100626, l10199) became stuck with the mc.The physician removed the coils through the mc and completed the procedure successfully by using the same mc and a competitor¿s coil.It is unknown if the event resulted in a loss of cerebral target position.There was no patient consequences.The surgery was delayed by five minutes due to the reported events.No other medical intervention was required.Additional information received indicated that all three coils were stretched after withdrawing.The microcatheter was not damaged during manipulation of the coil or noticed to be damaged upon removal from the patient.First, resistance was felt and then the device was totally before fluoro safe distance was something 20 cm from rhv.There was no notice of anything obstructing the microcatheter.Continuous flush on the microcatheter was maintained.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during coil advancement.No excessive force had been applied to the devices.The device was discarded; therefore, no additional investigation will be performed.A manufacturing record evaluation was performed for the finished device l16321 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 complaint of ¿ detachable coil delivery system (dcs) - impeded in microcatheter with no loss of cerebral target position¿ and ¿coil - 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 event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint devices; however, it is possible that clinical and procedural factors, including device manipulation / interaction, device selection, and the concomitant microcatheter, may have contributed to the reported issue.Stretching of the embolic coil occurs when an attempt is made to retract the device while a more distal part of the embolic coil is held in position, possibly by the resistance noted in the event description.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.
Event or Problem Description
As reported by a healthcare professional, during an intracranial coil embolization, two a 4x5mm micrusframe coils were used successfully as the first and second coils with a headway 17 microcatheter (mc).However, a 6mm x 15cm galaxy g3 coil (gly120615, l16321), a 6mm x 11.9cm micrusframe10 coil (mfr100611, l10198) and a 6mm x 26cm micrusframe10 coil (mfr100626, l10199) became stuck with the mc.The physician removed the coils through the mc and completed the procedure successfully by using the same mc and a competitor¿s coil.It is unknown if the event resulted in a loss of cerebral target position.There was no patient consequences.The surgery was delayed by five minutes due to the reported events.No other medical intervention was required.Additional information received indicated that all three coils were stretched after withdrawing.The microcatheter was not damaged during manipulation of the coil or noticed to be damaged upon removal from the patient.First, resistance was felt and then the device was totally before fluoro safe distance was something 20 cm from rhv.There was no notice of anything obstructing the microcatheter.Continuous flush on the microcatheter was maintained.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during coil advancement.No excessive force had been applied to the devices.
Additional Manufacturer Narrative
Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion updated with product analysis: as reported by a healthcare professional, during an intracranial coil embolization, two a 4x5mm micrusframe coils were used successfully as the first and second coils with a headway 17 microcatheter (mc).However, a 6mm x 15cm galaxy g3 coil (gly120615, l16321), a 6mm x 11.9cm micrusframe10 coil (mfr100611, l10198) and a 6mm x 26cm micrusframe10 coil (mfr100626, l10199) became stuck with the mc.The physician removed the coils through the mc and completed the procedure successfully by using the same mc and a competitor¿s coil.It is unknown if the event resulted in a loss of cerebral target position.There was no patient consequences.The surgery was delayed by five minutes due to the reported events.No other medical intervention was required.Additional information received indicated that all three coils were stretched after withdrawing.The microcatheter was not damaged during manipulation of the coil or noticed to be damaged upon removal from the patient.First, resistance was felt and then the device was totally before fluoro safe distance was something 20 cm from rhv.There was no notice of anything obstructing the microcatheter.Continuous flush on the microcatheter was maintained.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during coil advancement.No excessive force had been applied to the devices.One non-sterile galaxy g3 6mm x 15cm unit was received inside of a pouch.The received device was visually inspected, the dpu was found with several kinks.Then a microscopic inspection was performed, and the embolic coil was found stretched and mechanically detached from the device.No other damages were observed.A manufacturing record evaluation was performed for the finished device l16321 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿detachable coil delivery system (dcs) ¿ impeded in microcatheter with no loss of cerebral target position¿ could not be evaluated due the conditions of the received device, however, the conditions noted on the dpu may have contributed to an impediment and due to this we can confirm the complaint.The complaint reported by the customer ¿coil- unraveled/stretched-in microcatheter¿ was confirmed due the embolic coil was found stretched, however the exact time when this condition occurred could not be conclusively determined.The kinked and stretched condition appears to have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.Neither the device history record review nor the product analysis suggest that the reported failure could be related to the manufacturing process of the unit.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 event remains speculative and inconclusive, based on the limited information provided and without the return of the compliant devices; however, it is possible that clinical and procedural factors, including device manipulation/interaction, device selection, and the concomitant microcatheter, may have contributed to the reported issue.Stretching of the embolic coil occurs when an attempt is made to retract the device while a more distal part of the embolic coil is held in position, possibly by the resistance noted in the event description.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: 10005344
• Report Number: 3008114965-2020-00143
• Device Sequence Number: 2785166
• Product Code: KRD
• UDI-Device Identifier: 10886704077534
• UDI-Public: 10886704077534
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 04/07/2020

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: 06/30/2022
• Device Model Number: GLY120615
• Device Catalogue Number: GLY120615
• Device Lot Number: L16321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2020
• Initial Date Received by Manufacturer: 04/09/2020
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 04/28/2020
• Supplement Report FDA Received Date: 05/27/2020
• 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: HEADWAY 17 MICROCATHETER; MICRUSFRAME10 6MM X 11.9CM; MICRUSFRAME10 6MM X 26CM; TARGET XL COILS; TWO MICRUSFRAME 4X5MM COILS