MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT HEL 2MM X 8CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX120208
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a meningioma embolization, an approach was made from the right femoral artery with a sheath (6fr).The guiding catheter was approached to the left common carotid artery (lt-cca).A headway 21 microcatheter (mc) was advanced to the middle meningeal artery (mma) from the left external carotid artery (lt-eca), and the embolization was started.After the embossed-fair 300-500 was implanted, a 2mm x 8cm galaxy g3 coil (glx120208, l16361) was used for the additional embolization.The physician tried to insert the galaxy g3 into the microcatheter, but the galaxy g3 became ¿stuck¿ just a little way from the hub.The delivery wire slowly pulled but the device became unraveled.After the delivery wire was pulled more slowly, the coil was able to be removed and the procedure was able to be proceeded.When the guide wire was inserted into the microcatheter just in case, there was no resistance, therefore, another galaxy (same product number, different lot) was inserted.The product was used without any problem.The embolization/procedure was completed.A continuous flush was done.The lesion was lt-mma.Concomitant devices also include a guiding catheter (slim guide, 6fr).
Additional Manufacturer Narrative
Product complaint # (b)(4).Procode: krd/hcg.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.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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this 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).Updated sections on this medwatch: b4, b5, d9, e1, e2, e3, g3, g6, h2, h3, h6 and h10.Section b5: additional information received indicated that the complaint product was removed through the microcatheter, and the replaced coil was used successfully and safely with the same microcatheter.Nothing was noted to be obstructing the microcatheter.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 coil advancement.No excessive force was applied to the device.There was no blood flow restriction/reduction as a result of the event.No report that the procedure was prolonged due to the event.Section e1.Initial reporter phone: (b)(6).The product has been returned for evaluation and testing.However, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
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 meningioma embolization, an approach was made from the right femoral artery with a sheath (6fr).The guiding catheter was approached to the left common carotid artery (lt-cca).A headway 21 microcatheter (mc) was advanced to the middle meningeal artery (mma) from the left external carotid artery (lt-eca), and the embolization was started.After the embossed-fair 300-500 was implanted, a 2mm x 8cm galaxy g3 coil (glx120208, l16361) was used for the additional embolization.The physician tried to insert the galaxy g3 into the microcatheter, but the galaxy g3 became ¿stuck¿ just a little way from the hub.The delivery wire slowly pulled but the device became unraveled.After the delivery wire was pulled more slowly, the coil was able to be removed and the procedure was able to proceed.When the guide wire was inserted into the microcatheter just in case, there was no resistance, therefore, another galaxy (same product number, different lot) was inserted.The product was used without any problem.The embolization/procedure was completed.A continuous flush was done.The lesion was lt-mma.Concomitant devices also include a guiding catheter (slim guide, 6fr).Additional information received indicated that the complaint product was removed through the microcatheter, and the replaced coil was used successfully and safely with the same microcatheter.Nothing was noted to be obstructing the microcatheter.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 coil advancement.No excessive force was applied to the device.There was no blood flow restriction/reduction as a result of the event.No report that the procedure was prolonged due to the event.A non-sterile 2mm x 8cm galaxy g3 coil was received contained in the decontamination pouch.Upon arrival, the core wire of the galaxy g3 was observed to have multiple kinks along its entire length, also the introducer slit was found to be open, the core wire was protruding through the introducer slit.Further inspection under microscopic magnification revealed that the embolic coil was severely stretched inside of the introducer, and it remained attached to the resistance heating (rh) coil.No further damage was found on the device.The multiple kinked conditions observed in the core wire could be related to the handling process of the device since this damage is not documented on the complaint.It is also possible that in an attempt to overcome the immobility of the coil inside the microcatheter, undue force might have inadvertently been applied resulting in the multiple kinks and protruding condition found in the core wire.A manufacturing record evaluation was performed for the finished device, and no non-conformances related to the malfunction were identified.Coil stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issue from occurring.Stretching can occur during procedure handling where force may have been inadvertently applied.The complaint documented that the coil got stuck inside the microcatheter.It is possible that force may have inadvertently been applied during the coil removal from the microcatheter which resulted in the coil stretching.Based on the appearance of the embolic coil of the returned device, the issue documented in the complaint that the device became unraveled was confirmed.Although the impeded condition encountered during the procedure could not be replicated in the lab due to the conditions noted on the returned components, the damages noted in the core wire and the introducer components seem to be secondary to this issue; as such the customer complaint was confirmed.Factors not described within the information available might have contributed to the impeded condition that ultimately led to the coil stretching, the root cause remains unknown.However, 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 failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: ¿ if unusual friction is noticed during advancement or retraction of the microcoil system, verify the clear tab is unlocked and pulled out from the re-sheathing tool approximately 1 in.¿ 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.¿ 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.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 XSFT HEL 2MM X 8CM
• 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: 14601783
• Report Number: 3008114965-2022-00403
• Device Sequence Number: 6146698
• Product Code: KRD
• UDI-Device Identifier: 10886704077763
• UDI-Public: 10886704077763
• 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): 08/04/2022

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: 06/30/2022
• Device Model Number: GLX120208
• Device Catalogue Number: GLX120208
• Device Lot Number: L16361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 06/21/2022; 08/04/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 07/11/2022; 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2019
• 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: A SHEATH 6FR.; EMBOSSED-FAIR 300-500.; GUIDING CATHETER (SLIM GUIDE, 6FR).; HEADWAY 21 MICROCATHETER.
• Patient Sex: Unknown