MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 5MM X 10CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLY120510
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization, a galaxy g3 5mm x 10cm coil (gly120510, l16069) was being used for framing.The physician felt some sense of discomfort (i.E.Resistance) while manipulating the coil back and forth for several times, there is no information where the resistance was felt.The situation didn¿t change, so the coil was withdrawn from the patient.Continuous irrigation was maintained throughout the procedure.The used microcatheter was sl10, guide catheter was roadmaster (goodman).Reshipment pictures were provided.Additional information received indicated that it was not necessary to remove the microcatheter.The device did not appear damaged at any time.There was nothing 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.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.There was no excessive force applied to the device.Based on the visual analysis of the pictures received, the device contains foreign material.
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.Based on the visual analysis of the pictures received, the device contains foreign material.The findings meet regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg initial reporter phone: (b)(6).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.Based on the photos provided for this complaint, it can be noted that the embolic coil of the galaxy g3 5mm x 10cm has a protruding condition.However the distal body of the coil remain inside of the introducer, even though the coil could be noted tangled with the dpu no damages could be noted on it.One foreign white fibrous could be noted tangled in the coil.A microscopic evaluation will be performed once the device return for analysis.No other damages could be noted.A manufacturing record evaluation (mre) was performed for the finished device l16069 number, and no non-conformances related to the reported complaint condition were identified.The reported condition ¿detachable coil delivery system (dcs)- resistance/friction-during advancement with no loss of cerebral target position¿ could not be evaluated based on the pictures.However, the foreign white fibrous may have contribute to this resistance/friction felt, this could not be conclusively determined.The mre suggests that the failure reported by the customer could not be related to the manufacturing process.No corrective action will be taken at this time.Further investigation will be performed once the device returns for analysis.Complaint trends are monitored on a monthly basis as part of the company post market surveillance.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.
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 galaxy g3 5mm x 10cm coil (gly120510, l16069) was being used for framing.The physician felt some sense of discomfort (i.E.Resistance) while manipulating the coil back and forth for several times, there is no information where the resistance was felt.The situation didn¿t change, so the coil was withdrawn from the patient.The continuous irrigation was maintained throughout the procedure.The used microcatheter was sl10, guide catheter was roadmaster (goodman).Reshipment pictures were provided.Additional information received indicated that it was not necessary to remove the microcatheter.The device did not appear damaged at any time.There was nothing 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.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.There was no excessive force applied to the device.Based on the photos provided for this complaint, it can be noted that the embolic coil of the galaxy g3 5mm x 10cm has a protruding condition.However, the distal body of the coil remain inside of the introducer, even though the coil could be noted tangled with the dpu no damages could be noted on it.One foreign white fibrous could be noted tangled in the coil.A microscopic evaluation will be performed once the device return for analysis.No other damages could be noted.A manufacturing record evaluation (mre) was performed for the finished device l16069 number, and no non-conformances related to the reported complaint condition were identified.A non-sterile unit galaxy g3 5mm x 10cm was returned to cerenovus for evaluation.Cerenovus then conducted visual and microscopic inspection of the returned device, since a foreign material was observed on the embolic coil as reported in the pre-shipment pictures.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 embolic coil is protruded from introducer, no other damages was observed during the visual analysis.During the microscopic inspection it was noted that the embolic coil is protruded from introducer with a stretched condition, also a foreign material was observed entangled with the embolic coil.The stretched condition could have appeared during the manipulation of the galaxy g3 5mm x 10cm at the procedure time, however, the root cause of the stretched coil remains unconclusive based on the information currently available for review.Based on the findings above described, the customer complaint was confirmed.Due to the foreign material noted on the embolic coil, the foreign material was removed from the embolic coil and was sent to a fourier transform infrared spectroscopy (ft-ir) analysis to determine the material composition and potential source.Overall, from the obtained ft-ir results, it can be concluded that the chemical composition of the sample cannot be determined because it shows high noise to signal ratio due to the sample size, common vibration peaks such as c-h, o-h and c-o can be observed along with some silicone peaks, however, they can be assigned to any other material.The chemical composition/structure remains unknown.Since it was not possible to determine the composition/structure of the foreign material, the source and the exact time of origin remains unknown.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.Resistance/friction-during advancement is a potential procedural complication associated with the device.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does 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.If unusual friction is noticed during advancement or retraction of the microcoil system, verify the locking mechanism, or clear tab is unlocked and pulled out from the resheathing tool approximately 1 in (2-3 cm).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.After flushing, reinsert the introducer into the infusion catheter hub as described in ¿microcoil placement¿ section above.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.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.

• Brand Name: GALAXY G3 5MM X 10CM
• 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: 12569295
• Report Number: 3008114965-2021-00492
• Device Sequence Number: 19688001
• Product Code: KRD
• UDI-Device Identifier: 10886704077503
• UDI-Public: 10886704077503
• 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,Followup
• Report Date (Section B): 11/16/2021

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: 05/31/2022
• Device Model Number: GLY120510
• Device Catalogue Number: GLY120510
• Device Lot Number: L16069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 10/07/2021; 11/15/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 10/21/2021; 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2019
• 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: ROADMASTER GUIDE CATHETER (GOODMAN); SL10 MICROCATHETER
• Patient Sex: Unknown