MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1.5MM X 4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM915040
Medical Device Problem Codes	Entrapment of Device (1212); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
Type of Reportable Event	Serious Injury
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 l14219 number, and no non-conformances related to the malfunction were identified.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 company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
A report from the field indicated that during a coil embolization of an anterior communicating artery (acom) aneurysm, a 1.5mm x 4cm galaxy g3 mini coil (glm915040/l14219) became stuck in the concomitant headway 17 microcatheter (microvention).The coil was partially in the microcatheter and partially protruding from the distal tip and the coil could no longer be advanced out of the microcatheter.The physician then attempted to remove the coil, but it became entangled with the coil (size/brand/manufacturer not specified) that had been implanted prior to this coil and the coil came out to the parent vessel.Therefore, the physician implanted a stent (brand/manufacturer not specified) to complete the procedure.There was no report of patient injury.Additional information received on 30-sep-2021 was reviewed.The coil that deviated from the mother vessel was one of several coils that had already been placed.It cannot be identified because other companies' products had also been implanted.The deviated coil was secured to the vessel wall with additional stent placement.The complaint coil was retrieved.So far, the patient has had no adverse events due to the reported event.No further information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Section b5: additional information received on 04-nov-2021 indicated the size/brand/manufacturer of the coil that had been placed prior to the complaint coil is unknown.There was an adequate flush maintained through the devices.The length of time that the procedure was delayed due to the event was not provided, however, the procedural delay was not considered clinically significant.It was reported that excessive force was not applied to the device.Anonymized procedural films/imaging is not available for review.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: a report from the field indicated that during a coil embolization of an anterior communicating artery (acom) aneurysm, a 1.5mm x 4cm galaxy g3 mini coil (glm915040/l14219) became stuck in the concomitant headway 17 microcatheter (microvention).The coil was partially in the microcatheter and partially protruding from the distal tip and the coil could no longer be advanced out of the microcatheter.The physician then attempted to remove the coil, but it became entangled with the coil (size/brand/manufacturer not specified) that had been implanted prior to this coil and the coil came out to the parent vessel.Therefore, the physician implanted a stent (brand/manufacturer not specified) to complete the procedure.There was no report of patient injury.Additional information received on 30-sep-2021 was received indicating that the coil deviated from the mother vessel was one of several coils that had already been placed.It cannot be identified because other companies' products had also been implanted.Included.The deviated coil was secured to the vessel wall with additional stent placement.The complaint coil was retrieved.So far, the patient has had no adverse events due to the reported event.Additional information received on 04-nov-2021 indicated the size/brand/manufacturer of the coil that had been placed prior to the complaint coil is unknown.There was an adequate flush maintained through the devices.The length of time that the procedure was delayed due to the event was not provided, however, the procedural delay was not considered clinically significant.It was reported that excessive force was not applied to the device.Anonymized procedural films/imaging is not available for review.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device l14219 number, and no non-conformances related to the malfunction were identified.Coil impeded in microcatheter and entanglement requiring additional intervention are known potential procedural complications associated with the use of the galaxy g3 mini in coil embolization.Per the galaxy g3 mini instructions for use (ifu): if unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw and examine the delivery catheter system.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.With the information provided and without films and the return of the associated devices, it is not possible to determine the root cause of the event.However, the event may have been related to a combination of multiple factors experienced in the clinical setting rather than the design or manufacture of the device.The file will be re-reviewed if additional information is received at a later date.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: GALAXY G3 MINI 1.5MM X 4CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12655725
• Report Number: 3008114965-2021-00521
• Device Sequence Number: 13780317
• Product Code: KRD
• UDI-Device Identifier: 10886704080152
• UDI-Public: 10886704080152
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171862
• 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): 11/10/2021

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: 10/31/2021
• Device Model Number: GLM915040
• Device Catalogue Number: GLM915040
• Device Lot Number: L14219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEADWAY 17 MICROCATHETER (MICROVENTION).; HEADWAY 17 MICROCATHETER (MICROVENTION).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown