MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 2MM X 4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM920040
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
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 is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.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, a 2mm x 4cm galaxy g3 coil (glm920040, k10750) was being used as the second coil.The coil couldn't be advanced nor retrieved by the physician.The physician pulled the coil and the unspecified microcatheter (mc) at the same time.After inspection, it turns out to be stretched.The physician used a same like product.The procedure was successfully finished.There was no patient injury reported.
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: as reported by the field, during a coil embolization, a 2mm x 4cm galaxy g3 coil (glm920040, k10750) was being used as the second coil.The coil couldn't be advanced nor retrieved by the physician.The physician pulled the coil and the unspecified microcatheter (mc) at the same time.After inspection, it turns out to be stretched.The physician used a same like product.The procedure was successfully finished.There was no patient injury reported.The device was returned to cerenovus for further evaluation.A non-sterile galaxy g3 mini 2mm x 4cm was received contained in the decontamination pouch.Upon arrival, the device was visually inspected, and the introducer was returned separated from the unit, but no damages were found on it.No other damages were found in the device.Under microscopic magnification, the embolic coil was found to be stretched and with multiple kinks.A manufacturing record evaluation was performed for the finished device, and no non-conformances related to the malfunction were identified.Coil stretching and coil kinking are known potential issues associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issues from occurring.Stretching and kinking can occur during procedure handling where force may have been inadvertently applied.The complaint documented that the coil could not be advanced through nor retrieved from the concomitant microcatheter; the complaint coil and microcatheter were removed from the patient.It is possible that force may have inadvertently been applied during the coil advancement in attempt to overcome the resistance which resulted in the coil kinking.Similarly, force may have inadvertently been applied during the coil removal from the microcatheter which resulted in the coil stretching.Although the functional test could not be performed due to the conditions in which the device was received, the customer complaint was confirmed based on the appearance of the embolic coil.With the limited information available, an assignment of a root cause is not possible.However, it is suspected that the damages described above are the result of the manipulation required to advance and withdraw the embolic coil from the microcatheter.Factors not described in the event description, such as inadequate flush, may have contributed to the issue encountered during the procedure, however, this cannot be conclusively determined.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.A manufacturing record evaluation was performed, and no non-conformance was found during the review.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) contain the following precautions: if unusual friction is noticed during advancement or retraction of the microcoil system through the introducer, open the rhv main valve, and partially withdraw the distal end of the introducer to expose its tip within the rhv.Tighten the rhv main valve and flush the y-connector of the rhv with sterile saline and verify that fluid exits the slit in the clear portion of the introducer.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.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.If repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system.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 2MM 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14470303
• Report Number: 3008114965-2022-00359
• Device Sequence Number: 4507133
• Product Code: KRD
• UDI-Device Identifier: 10886704080305
• UDI-Public: 10886704080305
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

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: 01/31/2023
• Device Model Number: GLM920040
• Device Catalogue Number: GLM920040
• Device Lot Number: K10750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2020
• 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: UNSPECIFIED MICROCATHETER
• Patient Sex: Unknown