MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 6MM X 20CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLY120620
Medical Device Problem Codes	Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
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.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device l13267 number, and no non-conformances related to the reported complaint condition were identified.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by the field, during a coil embolization of the anterior communicating artery (a-com), a 6mmx20cm galaxy coil (gly120620, l13267) was used as the first coil but there was an intensive resistance felt when it was advanced through a (sl10, stryker microcatheter (mc).The complaint coil was re-sheathed but there was resistance during re-sheathing.The physician retracted the delivery wire with some force, but the coil got unraveled.It was replaced with another same sized coil and the procedure was completed.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Section b5: additional information received indicated that the resistance was felt inside the mc.The event did not result loss of cerebral target position.The device was able to move.Nothing was noted to be obstructing the microcatheter.A continuous flush on the microcatheter was maintained.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.No excessive force was applied to the device.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 the field, during a coil embolization of the anterior communicating artery (a-com), a 6mmx20cm galaxy coil (gly120620, l13267) was used as the first coil but there was an intensive resistance felt when it was advanced through a (sl10, stryker microcatheter (mc).The complaint coil was re-sheathed but there was resistance during re-sheathing.The physician retracted the delivery wire with some force, but the coil got unraveled.It was replaced with another same sized coil and the procedure was completed.Additional information received indicated that the resistance was felt inside the mc.The event did not result loss of cerebral target position.The device was able to move.Nothing was noted to be obstructing the microcatheter.Continuous flush on the microcatheter was maintained.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.No excessive force was applied to the device.Additional information received indicated that the resistance was felt inside the mc.The event did not result loss of cerebral target position.The device was able to move.Nothing was noted to be obstructing the microcatheter.Continuous flush on the microcatheter was maintained.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.No excessive force was applied to the device.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device l13267 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 ¿resistance/friction¿ and ¿unraveled¿ could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the event is related to the device manufacturing process.The instructions for use (ifu) caution that if unusual friction is still noticed during advancement or retraction of the coil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire catheter system and examine for damage.Replace it with a new system.If friction still exists, withdraw and examine the delivery catheter system.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 issues.An embolic coil becomes unraveled when an excessive force is applied to the device.As noted in the event description, the user retracted the delivery wire with some force, which could have contributed to the coil becoming unraveled.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 20CM
• 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: 12075364
• Report Number: 3008114965-2021-00263
• Device Sequence Number: 3427328
• Product Code: KRD
• UDI-Device Identifier: 10886704077541
• UDI-Public: 10886704077541
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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: 07/31/2021
• Device Model Number: GLY120620
• Device Catalogue Number: GLY120620
• Device Lot Number: L13267
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 07/19/2021
• 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, STRYKER MICROCATHETER; SL10, STRYKER MICROCATHETER