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	11/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Procode is krd/hcg.The name, phone and email address of the initial reporter are not available / 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 review of manufacturing documentation associated with this lot (30504546) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during a coil embolization procedure targeting a pancreatic arcade artery aneurysm, the 2mm x 8cm galaxy g3 xsft helical coil (glx120208 / 30504546) was inserted into a concomitant carnelian® marvel® microcatheter (tokai medical) and the coil was delivered to the lesion.It was reported that it was ¿impossible¿ to push the delivery wire back and forth when the coil part came out from the distal end of the microcatheter.The physician managed to remove the coil with force; the physician observed the removed complaint device and the junction part of the wire and the coil was unraveled.It was replaced with another coil and the procedure was completed.Continuous flush was maintained.The physician commented that it was unknown if the cause of the coil unraveling was due to the microcatheter or to the complaint coil.However, the microcatheter was used after the complaint coil was removed.Therefore, it was highly possible that the complaint coil malfunctioned.There was no report of any patient adverse event or complication associated with the reported issue.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 10-dec-2021.A supplemental 3500a report will be submitted once the product investigation has been completed.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during a coil embolization procedure targeting a pancreatic arcade artery aneurysm, the 2mm x 8cm galaxy g3 xsft helical coil (glx120208 / 30504546) was inserted into a concomitant carnelian® marvel® microcatheter (tokai medical) and the coil was delivered to the lesion.It was reported that it was ¿impossible¿ to push the delivery wire back and forth when the coil part came out from the distal end of the microcatheter.The physician managed to remove the coil with force; the physician observed the removed complaint device and the junction part of the wire and the coil was unraveled.It was replaced with another coil and the procedure was completed.Continuous flush was maintained.The physician commented that it was unknown if the cause of the coil unraveling was due to the microcatheter or to the complaint coil.However, the microcatheter was used after the complaint coil was removed.Therefore, it was highly possible that the complaint coil malfunctioned.There was no report of any patient adverse event or complication associated with the reported issue.On 30-nov-2021, additional information was received.The information indicated that there was no difficulty positioning the coil in the target site.There was no difficulty in getting the coil to conform to the aneurysm wall; the coil was able to conform to the aneurysm wall.There was no resistance between the guidewire and the microcatheter when the target site was being accessed.The reported event did not result in a clinically significant delay in the procedure.The complaint device was received for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 2mm x 8cm galaxy g3 xsft helical coil was received coiled and contained in a pouch.Visual inspection was performed.The core wire was observed kinked at 18.5 inches from the proximal end.No other damages nor anomalies were observed during the visual inspection.Microscopic inspection was performed.The embolic coil component was observed in stretched condition.Functional test could not be performed due to the condition of the returned complaint device.A review of manufacturing documentation associated with this lot (30504546) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The complaint documented that during a coil embolization procedure targeting a pancreatic arcade artery aneurysm, the complaint coil was inserted in to the concomitant microcatheter and delivered to the lesion; it was ¿impossible¿ to push the delivery wire back and forth when the coil part came out from the distal end of the microcatheter.The physician managed to remove the coil with force; the physician observed the removed complaint device and the junction part of the wire and the coil was unraveled.The reported issue associated with the coil being impeded in the microcatheter was confirmed; the core wire was observed kinked during the visual inspection and the embolic coil was observed stretched under magnification during the microscopic inspection.The exact time when the coil became stretched cannot be conclusively determined.Although no conclusion could be reached on the cause of the reported event, the instructions for use (ifu) does contain the following precaution: ¿ 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.¿ 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.Coil stretching / unraveling 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.Coil stretching / unraveling can occur during attempts to withdrawal the coil against resistance.The complaint reported that there was when the coil was delivered to the target lesion, it was ¿impossible¿ to push the delivery wire back and forth when the coil came out of the distal end of the concomitant microcatheter.Then the physician managed to remove the coil with force; it is possible that the embolic coil became stretched when it was being removed; where the force exerted on it may have resulted in the reported unraveled / stretched condition.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 30-nov-2021.[additional information]: the healthcare professional reported that during a coil embolization procedure targeting a pancreatic arcade artery aneurysm, the 2mm x 8cm galaxy g3 xsft helical coil (glx120208 / 30504546) was inserted into a concomitant carnelian® marvel® microcatheter (tokai medical) and the coil was delivered to the lesion.It was reported that it was ¿impossible¿ to push the delivery wire back and forth when the coil part came out from the distal end of the microcatheter.The physician managed to remove the coil with force; the physician observed the removed complaint device and the junction part of the wire and the coil was unraveled.It was replaced with another coil and the procedure was completed.Continuous flush was maintained.The physician commented that it was unknown if the cause of the coil unraveling was due to the microcatheter or to the complaint coil.However, the microcatheter was used after the complaint coil was removed.Therefore, it was highly possible that the complaint coil malfunctioned.There was no report of any patient adverse event or complication associated with the reported issue.On 30-nov-2021, additional information was received.The information indicated that there was no difficulty positioning the coil in the target site.There was no difficulty in getting the coil to conform to the aneurysm wall; the coil was able to conform to the aneurysm wall.There was no resistance between the guidewire and the microcatheter when the target site was being accessed.The reported event did not result in a clinically significant delay in the procedure.E.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-8687
• MDR Report Key: 12824709
• Report Number: 3008114965-2021-00549
• Device Sequence Number: 1521004
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/14/2021

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: 12/31/2023
• Device Model Number: GLX120208
• Device Catalogue Number: GLX120208
• Device Lot Number: 30504546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 11/30/2021; 12/10/2021; 12/14/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 12/01/2021; 12/13/2021; 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• 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: CARNELIAN® MARVEL® MICROCATHETER (TOKAI MEDICAL)
• Patient Sex: Unknown