MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 6MM X 20CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLY120620
Medical Device Problem Codes	Material Rupture (1546); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Procode is krd/hcg.Conclusion: the healthcare professional reported that during a coil embolization procedure for a dural arteriovenous fistula (davf), an approach was made from the left femoral artery with a 4fr sheath.An angio catheter was advanced toward the left common carotid artery (cca).An approach was made from the right femoral vein (fv) with a 6fr sheath.A guiding catheter was inserted and advanced toward the left jugular vein (jv).From there, a tactics intermediate catheter (technocrat corporation) and an excelsior® sl-10® microcatheter (stryker) were advanced together to the left transverse sinus (ts) and embolization was started.After implanting several competitor coils, the 8mm x 24cm galaxy g3 coil (gly120824 / 30692225) was opened for the purpose of implantation.It was prepared and inserted into the microcatheter.Although the physician tried to embolize the target site, it herniated from the lesion a little bit; as a result, the physician tried to resheath the coil.It was reported that at that time, the introducer sheath did not return to its original shape even when the resheathing tool was sliding.The delivery wire was exposed midway making it difficult to resheath.As a result, the entire delivery system was removed from the patient¿s body.Subsequently, additional embolization was performed with a competitor product.After which, the 6mm x 20cm galaxy g3 coil (gly120620 / 30666675) was opened for the purpose of implant.This coil was inserted into the microcatheter.A resheathing attempt was made because the target lesion did not expand as much as the physician intended to embolize.However, the introducer sheath did not return to its original shape even when the resheathing tool was sliding.The delivery wire was exposed midway, making it difficult to resheath.Therefore, the entire delivery system was removed from the patient¿s body.The procedure was completed with competitors¿ product.It was reported that continuous flush was maintained.The products are not available to be returned.There was no report of any patient adverse event or complication.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30666675) 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.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Positioning difficulty / poor conformability is a known potential issue associated with the use of the device.With the limited information available and without the product available for analysis, the reported customer complaint cannot be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size / vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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.This is one of products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00133.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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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 for a dural arteriovenous fistula (davf), an approach was made from the left femoral artery with a 4fr sheath.An angio catheter was advanced toward the left common carotid artery (cca).An approach was made from the right femoral vein (fv) with a 6fr sheath.A guiding catheter was inserted and advanced toward the left jugular vein (jv).From there, a tactics intermediate catheter ((b)(4)) and an excelsior® sl-10® microcatheter (stryker) were advanced together to the left transverse sinus (ts) and embolization was started.After implanting several competitor coils, the 8mm x 24cm galaxy g3 coil (gly120824 / 30692225) was opened for the purpose of implantation.It was prepared and inserted into the microcatheter.Although the physician tried to embolize the target site, it herniated from the lesion a little bit; as a result, the physician tried to resheath the coil.It was reported that at that time, the introducer sheath did not return to its original shape even when the resheathing tool was sliding.The delivery wire was exposed midway making it difficult to resheath.As a result, the entire delivery system was removed from the patient¿s body.Subsequently, additional embolization was performed with a competitor product.After which, the 6mm x 20cm galaxy g3 coil (gly120620 / 30666675) was opened for the purpose of implant.This coil was inserted into the microcatheter.A resheathing attempt was made because the target lesion did not expand as much as the physician intended to embolize.However, the introducer sheath did not return to its original shape even when the resheathing tool was sliding.The delivery wire was exposed midway, making it difficult to resheath.Therefore, the entire delivery system was removed from the patient¿s body.The procedure was completed with competitors¿ product.It was reported that continuous flush was maintained.The products are not available to be returned.There was no report of any patient adverse event or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 24-mar-2022.[additional information]: on 24-mar-2022, additional information was received.The information indicated that the 6mm x 20cm galaxy g3 coil did not expand as the physician had intended when it was used to embolize the target lesion.It is unclear how many times the coil had been withdrawn and repositioned, but the cerenovus sales representative thinks it was put in and out several times because it was rolled up larger than he expected.The coil was still attached to its respective delivery system when it was removed.The coil was not stretched nor damaged when it was removed.The clear tab of the introducer sheath had been pulled out and away from the re-sheathing tool at a 45-degree angle to unlock the microcoil.There was no clinically significant delay in the procedure as a result of the reported issue.E.1: initial reporter phone: (b)(6).The initial reporter email address was not provided.This is one of products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00133 and 3008114965-2022-00134.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 6MM X 20CM
• 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: 13691114
• Report Number: 3008114965-2022-00134
• Device Sequence Number: 4930329
• Product Code: KRD
• UDI-Device Identifier: 10886704077541
• UDI-Public: 10886704077541
• 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
• Report Date (Section B): 03/25/2022

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: 09/30/2024
• Device Model Number: GLY120620
• Device Catalogue Number: GLY120620
• Device Lot Number: 30666675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 03/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2021
• 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: EXCELSIOR® SL-10® MICROCATHETER (STRYKER).; TACTICS INTERMEDIATE CATHETER (TECHNOCRAT CORP).
• Patient Sex: Unknown