MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 3MM X 8CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLY120308
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization to the major aortopulmonary collateral arteries, an approach was made from the right femoral artery with a sheath (4f).An angio catheter was advanced toward the right subclavian artery.From there, the microcatheter (leonismova standard) was advanced to the collateral and shunt point approach was performed.Embolization was started.After several unspecified coils were implanted, a galaxy g3 3mm x 8cm coil (gly120308, 30737322) was used as an added coil.However, the complaint coil was attempted to be detached with the enpower control cable (ecb00018200, 30789762) but the complaint coil was unable to be detached even though the detachment button was pressed.The position of the delivery wire was changed about ten times, but the same issue continued.The complaint cable was able to have detached other coils until this detachment failure.The complaint coil was replaced with another cable and the deployment button was pressed about five times and the complaint coil was detached.The procedure was completed.There was no negative impact on the patient.It is unknown if a continuous flush performed.The lesion was the collateral from the right subclavian artery.Other concomitant device is a guiding catheter (nipro angiography catheter jr).
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30737322 number, and no non-conformances related to the malfunction were identified.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.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)(6).Updated sections on this medwatch: b4, b5, e1, e2, e3, g3, g6, h2, h4 and h10.Section b5: additional information received indicated that it is unknown of pre-deployment electrical testing was performed.The same dcb was used successfully with subsequent coils.The coil was still attached to the coil delivery system when removed from the patient.Section e1.Initial reporter phone: (b)(6).Complaint conclusion: as reported by the field, during a coil embolization to the major aortopulmonary collateral arteries, an approach was made from the right femoral artery with a sheath (4f).An angio catheter was advanced toward the right subclavian artery.From there, the microcatheter (leonismova standard) was advanced to the collateral and shunt point approach was performed.Embolization was started.After several unspecified coils were implanted, a galaxy g3 3mm x 8cm coil (gly120308, 30737322) was used as an added coil.However, the complaint coil was attempted to be detached with the enpower control cable (ecb00018200, 30789762) but the complaint coil was unable to be detached even though the detachment button was pressed.The position of the delivery wire was changed about ten times, but the same issue continued.The complaint cable was able to have detached other coils until this detachment failure.The complaint coil was replaced with another cable and the deployment button was pressed about five times and the complaint coil was detached.The procedure was completed.There was no negative impact on the patient.It is unknown if a continuous flush was performed.The lesion was the collateral from the right subclavian artery.Other concomitant device is a guiding catheter (nipro angiography catheter jr).Additional information received indicated that it is unknown of pre-deployment electrical testing was performed.The same dcb was used successfully with subsequent coils.The coil was still attached to the coil delivery system when removed from the patient.The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30737322 number, and no non-conformances related to the malfunction were identified.Failure to detach is a known potential issue associated with the use of this device.The instructions for use (ifu) contains several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.With the information available and without the product available for analysis, the reported customer complaint of could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: GALAXY G3 3MM 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15708136
• Report Number: 3008114965-2022-00692
• Device Sequence Number: 5144853
• Product Code: KRD
• UDI-Device Identifier: 10886704077466
• UDI-Public: 10886704077466
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2022

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: 12/31/2024
• Device Model Number: GLY120308
• Device Catalogue Number: GLY120308
• Device Lot Number: 30737322
• 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: 10/12/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• 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: DELTAFILL18 3MM X 12CM; DELTAFILL18 3MM X 12CM; ENPOWER CONTROL CABLE; LEONISMOVA STANDARD MICROCATHETER; NIPRO ANGIOGRAPHY CATHETER JR; SHEATH (4F)
• Patient Sex: Unknown