MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 2.5MM X 5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX122505
Medical Device Problem Codes	Material Rupture (1546); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Procode: krd/hcg initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device was discarded therefore no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device 30637472 number, and no non-conformances related to the malfunction were identified.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers 3008114965-2022-00329.
Event or Problem Description
As reported by the field, during a procedure of the major aortopulmonary collateral arteries (mapcas), a sheath (4fr) was inserted from the right femoral artery and an angio catheter approached to the aorta to insert into the right bronchial artery.A concomitant microcatheter (leonismove) was inserted into the patient and advanced toward a shunt point.After coil embolization was done with competitive coils, a 2mm x 2cm galaxy g3 coil (glx120202, 30532745) was inserted.However, it was unable to be pushed as the complaint coil comes out from the microcatheter.It was highly likely that the 2mm x 2cm was delivered with the tail of the first completive coil remaining at the tip of microcatheter (mc), and both coils were involved at the tip of microcatheter.It became impossible to press, so when the physician tried to remove it, but it became unraveled.The complaint coil was removed together with the microcatheter.Embolization was resumed by approaching with microcatheter again.After several coils were placed, a 2.5mm x 5cm galaxy g3 coil (glx122505, 30637472) was used for additional embolization.The coil was inserted and wound into several windings, but the windings protruded more than expected.Therefore, the physician attempted to retrieve this complaint coil.However, the introducer sheath did not restore to the original position even after sliding the re-sheath tool, and the delivery wire protruded from the slit on the way.Therefore, the coil delivery system was removed from the microcatheter.After that, another coil was used, and the coil was wound as expected.Therefore, the embolization was completed, and no patient injury was reported.It was unclear if continuous flush was done.The lesion was the right bronchial artery.
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.Section b5: additional information received indicated that there was no blood flow restriction/reduction as a result of the event.No excessive force was used at anytime with the galaxy g3 xsft 2mm x 2cm.The galaxy g3 xsft 2.5mm x 5cm had not been withdrawn and repositioned.There was no deployment difficulty with the galaxy g3 xsft 2.5mm x 5cm as a result in microcatheter kickback.The galaxy g3 xsft 2.5mm x 5cm coil was still attached to the coil delivery system when removed.The concomitant devices functioned.Section e1.Initial reporter phone: (b)(6).Complaint conclusion: as reported by the field, during a procedure of the major aortopulmonary collateral arteries (mapcas), a sheath (4fr) was inserted from the right femoral artery and an angio catheter approached to the aorta to insert into the right bronchial artery.A concomitant microcatheter (leonismove) was inserted into the patient and advanced toward a shunt point.After coil embolization was done with competitive coils, a 2mm x 2cm galaxy g3 coil (glx120202, 30532745) was inserted.However, it was unable to be pushed as the complaint coil comes out from the microcatheter.It was highly likely that the 2mm x 2cm was delivered with the tail of the first competitive coil remaining at the tip of microcatheter (mc), and both coils were involved at the tip of microcatheter.It became impossible to press, so when the physician tried to remove it, it became unraveled.The complaint coil was removed together with the microcatheter.Embolization was resumed by approaching with the microcatheter again.After several coils were placed, a 2.5mm x 5cm galaxy g3 coil (glx122505, 30637472) was used for additional embolization.The coil was inserted and wound into several windings, but the windings protruded more than expected.Therefore, the physician attempted to retrieve this complaint coil.However, the introducer sheath did not restore to the original position even after sliding the re-sheath tool, and the delivery wire protruded from the slit on the way.Therefore, the coil delivery system was removed from the microcatheter.After that, another coil was used, and the coil was wound as expected.Therefore, the embolization was completed, and no patient injury was reported.It was unclear if continuous flush was done.The lesion was the right bronchial artery.Additional information received indicated that there was no blood flow restriction/reduction as a result of the event.No excessive force was used at anytime with the galaxy g3 xsft 2mm x 2cm.The galaxy g3 xsft 2.5mm x 5cm had not been withdrawn and repositioned.There was no deployment difficulty with the galaxy g3 xsft 2.5mm x 5cm as a result in microcatheter kickback.The galaxy g3 xsft 2.5mm x 5cm coil was still attached to the coil delivery system when removed.The concomitant devices functioned.The device was discarded therefore no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device 30637472 number, and no non-conformances related to the malfunction were identified.Positioning difficulty of a coil is a known potential product failures associated with the use of the device.The instructions for use (ifu) contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.The ifu instructs on proper positioning of the microcoil system.The ifu also warns: ¿if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system¿.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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 XSFT 2.5MM X 5CM
• 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: 14345515
• Report Number: 3008114965-2022-00330
• Device Sequence Number: 17317962
• Product Code: KRD
• UDI-Device Identifier: 10886704077626
• UDI-Public: 10886704077626
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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: 07/31/2024
• Device Model Number: GLX122505
• Device Catalogue Number: GLX122505
• Device Lot Number: 30637472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2021
• 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: GALAXY G3 XSFT 2MM X 2CM.; LEONISMOVE MICROCATHETER.; UNSPECIFIED SHEATH (4FR).
• Patient Sex: Unknown