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

Model Number	GLM915040
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
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 as being damaged, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.(b)(6).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.Complaint conclusion: as reported by the field, during a coil embolization, a galaxy g3 mini coil 1.5mm x 4cm (glm915040, 30490129) was inserted from a sl-10 45° microcatheter, stryker but the complaint coil became stuck on the way.It was removed together with the microcatheter (mc) and the complaint coil was replaced with another coil and the procedure was completed.Additional information received indicated that the coil was not damaged in any way.There was nothing noted to be obstructing the microcatheter.A continuous flush on the microcatheter was maintained.The introducer was flushed until the liquid was visible at the distal end of the slit in the clear tube.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.No excessive force was applied to the device.A non-sterile galaxy g3 mini 1.5mm x 4cm was received for analysis, the device was inspected, and it was found that the core wire is kinked and protruded from introducer, no other damages or anomalies were observed during the visual analysis.The device was inspected under a microscope, and it was found that the embolic coil has a damaged condition.The functional test could not be performed due to the core wire is kinked and protruded from introducer.A manufacturing record evaluation (mre) was performed for the finished device 30490129 number, and no non-conformance was found during the review.Cerenovus conducted a visual inspection and microscopic examination of the returned device.A functional test could not be performed due to the conditions in which the device was returned.The visual analysis of the returned sample determined that the core wire is kinked and protruded from introducer, this condition is related with the customer complaint regarding ¿detachable coil delivery system (dcs) - impeded in microcatheter with no loss of cerebral target position¿.Procedural and other factors may contribute to the finding; however, this cannot be conclusively determined.Based on the findings during the visual analysis, the customer complaint was confirmed.A microscopic test was performed, and it was found that the embolic coil has a damaged condition.Procedural and other factors may contribute to the finding; however, this cannot be conclusively determined.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.Impeded in microcatheter is a known potential product failure associated with the use of the device.It should be noted that product failure is multifactorial.Although no conclusion could be reach on the cause of the reported event, the instructions for use (ifu) contain the following recommendations: ¿ do not fasten the rhv valve too tightly around the introducer sheath since excessive pressure may cause damage to the introducer sheath and/or the microcoil as it is advanced into the infusion microcatheter.Additionally, if the introducer tip and microcatheter hub are misaligned, damage may occur to the microcoil as it passes through this transition.¿ never advance, withdraw, or torque the delivery tube against resistance without first determining the cause of resistance under fluoroscopy.Manipulation of the delivery tube against resistance can cause damage and/or premature detachment of the coil.If unusual friction is noted within the infusion catheter, remove the detachable coil system.Refer to coil retrieval.If friction is noted with any subsequent detachable coil system, carefully examine the detachable coil system and the infusion catheter for possible damage.Replace both if necessary.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.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.
Event or Problem Description
As reported by the field, during a coil embolization, a galaxy g3 mini coil 1.5mm x 4cm (glm915040, 30490129) was inserted from a sl-10 45° microcatheter, stryker but the complaint coil became stuck on the way.It was removed together with the microcatheter (mc) and the complaint coil was replaced with another coil and the procedure was completed.Additional information received indicated that the coil was not damaged in any way.There was nothing noted to be obstructing the microcatheter.A continuous flush on the microcatheter was maintained.The introducer was flushed until the liquid was visible at the distal end of the slit in the clear tube.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.No excessive force was applied to the device.Based on the analysis of the device received, the embolic coil has a damaged condition.

• 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: 12769937
• Report Number: 3008114965-2021-00560
• Device Sequence Number: 4326560
• 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
• Report Date (Section B): 11/08/2021

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: 11/30/2023
• Device Model Number: GLM915040
• Device Catalogue Number: GLM915040
• Device Lot Number: 30490129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2020
• 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: SL-10 45° MICROCATHETER, STRYKER
• Patient Sex: Unknown