MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 3.5MM X 9CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLY123509
Medical Device Problem Codes	Stretched (1601); Difficult to Advance (2920); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Procode: procode is krd/hcg.[conclusion]: the healthcare professional reported that an aneurysm was confirmed at the gastroduodenal artery (gda), and coil embolization was performed.It was initially planned to embolize the aneurysm, ¿but approach was impossible resulting in a maternal embolism.¿ details of the procedure is as follows: a shepherd hook catheter (merit medical) approached the celiac artery with the 150cm x 5cm prowler select plus microcatheter (606s255x / 30883120).The prowler select plus microcatheter approached for aneurysm isolation and coil embolization was initiated.The complaint coil, a 3.5mm x 9cm galaxy g3 (gly123509 / 30704828) was flushed as continuous flush was not maintained.However, it was reported that the complaint coil was unable to advance through the middle part of the microcatheter.Resistance was felt.The delivery wire was retracted but there was no coil; the physician judged that the complaint coil had unraveled.The coil and microcatheter were removed.The prowler select plus microcatheter was replaced with a terumo microcatheter and the complaint coil was replaced with another 3.5mm x 9cm galaxy g3 (gly123509).The replacement coil was implanted and the procedure was completed.There was no negative patient impact reported.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot: (30704828) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.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.With the information available and without the complaint product available to be returned for analysis, the reported issue in the 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 may have contributed to the reported failure.Based on the device history record 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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 an aneurysm was confirmed at the gastroduodenal artery (gda), and coil embolization was performed.It was initially planned to embolize the aneurysm, ¿but approach was impossible resulting in a maternal embolism.¿ details of the procedure is as follows: a shepherd hook catheter (merit medical) approached the celiac artery with the 150cm x 5cm prowler select plus microcatheter (606s255x / 30883120).The prowler select plus microcatheter approached for aneurysm isolation and coil embolization was initiated.The complaint coil, a 3.5mm x 9cm galaxy g3 (gly123509 / 30704828) was flushed as continuous flush was not maintained.However, it was reported that the complaint coil was unable to advance through the middle part of the microcatheter.Resistance was felt.The delivery wire was retracted but there was no coil; the physician judged that the complaint coil had unraveled.The coil and microcatheter were removed.The prowler select plus microcatheter was replaced with a terumo microcatheter and the complaint coil was replaced with another 3.5mm x 9cm galaxy g3 (gly123509).The replacement coil was implanted and the procedure was completed.There was no negative patient impact reported.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 10-mar-2023.[additional information]: on 10-mar-2023, additional information was received.The information provided clarification on what ¿maternal embolism¿ meant ¿embolization of parent vessel.It was not an adverse event, the information confirmed that there was no patient injury.The embolic coil did not prematurely detach at the detachment zone on the device positioning unit.The coil had not been withdrawn and repositioned.There was no resistance between the guidewire and the microcatheter when the target site was being accessed.There were no kinks on the microcatheter that may have contributed to the reported issue.There was no additional damage noted on the coil aside from the reported unraveled condition when it was removed.There was no blood flow restriction / reduction as a result of the reported issue.E.1: initial reporter phone: (b)(6).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 3.5MM X 9CM
• 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 ; 303552-6892
• MDR Report Key: 16305474
• Report Number: 3008114965-2023-00062
• Device Sequence Number: 6767489
• Product Code: KRD
• UDI-Device Identifier: 10886704077442
• UDI-Public: 10886704077442
• 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): 03/10/2023

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: 11/30/2024
• Device Model Number: GLY123509
• Device Catalogue Number: GLY123509
• Device Lot Number: 30704828
• 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: 01/19/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2021
• 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: CHEVALIER® 14 GUIDEWIRE (CORDIS); PROWLER SELECT PLUS 150/5CM; SHEPHERD HOOK CATHETER (MERIT MEDICAL)
• Patient Sex: Unknown