MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1.5MM X 2CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM915020
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Material Twisted/Bent (2981); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.Based on the analysis, the embolic coil is stretched.The findings meet us regulatory reporting criteria.Complaint conclusion: as reported by the field, during a coil embolization to an aneurysm to the right posterior communicating artery confirmed by angiography, an unspecified microcatheter (mc) was delivered to the upper third of the aneurysm.The three unspecified coils were delivered and detached successfully.Finally, the fourth and last coil, a galaxy g3 mini 1.5mm x 2cm (glm915020, 30772759) was delivered to fill the aneurysm.There is only a little space left in the aneurysm, it was found that the coil cannot be filled into the aneurysm completely after multiple adjustments.Finally, due to the deviation of the microcatheter tip, the physician intends to retract the coil and adjust the position of microcatheter.It was found that the delivery wire could not be retrieved into the introducer sheath, after several attempts, it still failed.The physician tried to deliver the coil to the microcatheter again but failed.The delivery wire of the coil was found to be kinked/bent.A new coil was switched to complete the surgery.The microcatheter was not replaced.There was no patient injury report.Additional information was received indicating that there was no patient injury reported.There were no procedural delays due to the event.It was further clarified that the coil could not be filled with the aneurysm completely.There was no damage noted to the sheath introducer.There was no split and the delivery wire nor the coil were noted to be protruding from the introducer.There was no resistance at any time during advancement of the coil through the mc.The coil was not positioned at a relatively sharp angle to the microcatheter.Two pictures were attached to the complaint file in which it was noted that the core wire is protruding from the introducer, and multiple kinked conditions were noted on it.Also, the introducer was noted with a kinked condition.The coil was not able to be seen in the picture.A non-sterile galaxy g3 mini 1.5mm x 2cm was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and the core wire was noted to be protruding from the introducer and multiple kinked were found on it.The coil was inside the introducer.These damages are consistent with the damages seen in the provided pictures.The device was inspected under microscopic magnification, and it was found that the embolic coil is stretched; it remains attached to the resistance heating (rh) coil.No other damages were found in the device.The introducer was found opened by a kinked condition at the point where the core wire protrudes.Coil positioning difficulty cannot be replicated in the laboratory since the reported issue is specific to the patient and procedure at the time of occurrence.However, positioning difficulty is a known potential issue associated with the use of the device.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.According to the risk documentation, inability to fit the coil into the aneurysm or to achieve coil stability is a potential failure mode that can occur during microcoil placement and can result in the coil being advanced and withdrawn repeatedly to obtain desired shape and configuration in the aneurism, resulting in the coil stretching.The complaint detailed that the coil could not be completely filled into the aneurysm after multiple adjustments, this manipulation may have resulted in the coil stretching and core wire kinking, which ultimately led to the inability to resheath the coil.The event reported regarding the delivery wire not being able to be retrieved into the introducer sheath and the delivery wire kinking was confirmed based on the appearance of the returned device, which is secondary to the positioning difficulty.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) does contain the following recommendations: 1.To obtain proper positioning of the microcoil system for detachment under fluoroscopic guidance, align the radiopaque marker on the dpu wire just past the proximal marker band on the tip of the microcatheter.2.Once the desired microcoil placement has been achieved, gently tighten the rhv around the dpu wire to maintain its position.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.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.
Event or Problem Description
As reported by the field, during a coil embolization to an aneurysm to the right posterior communicating artery confirmed by angiography, an unspecified microcatheter (mc) was delivered to the upper third of the aneurysm.The three unspecified coils were delivered and detached successfully.Finally, the fourth and last coil, a galaxy g3 mini 1.5mm x 2cm (glm915020, 30772759) was delivered to fill the aneurysm.There is only a little space left in the aneurysm, it was found that the coil cannot be filled into the aneurysm completely after multiple adjustments.Finally, due to the deviation of the microcatheter tip, the physician intends to retract the coil and adjust the position of microcatheter.It was found that the delivery wire could not be retrieved into the introducer sheath, after several attempts, it still failed.The physician tried to deliver the coil to the microcatheter again but failed.The delivery wire of the coil was found to be kinked/bent.A new coil was switched to complete the surgery.The microcatheter was not replaced.There was no patient injury report.Additional information was received indicating that there was no patient injury reported.There were no procedural delays due to the event.It was further clarified that the coil could not be filled with the aneurysm completely.There was no damage noted to the sheath introducer.There was no split and the delivery wire nor the coil were noted to be protruding from the introducer.There was no resistance at any time during advancement of the coil through the mc.The coil was not positioned at a relatively sharp angle to the microcatheter.

• Brand Name: GALAXY G3 MINI 1.5MM X 2CM
• 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: 16362108
• Report Number: 3008114965-2023-00106
• Device Sequence Number: 12605237
• Product Code: KRD
• UDI-Device Identifier: 10886704080138
• UDI-Public: 10886704080138
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K171862
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2023

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: 02/28/2025
• Device Model Number: GLM915020
• Device Catalogue Number: GLM915020
• Device Lot Number: 30772759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2023
• Initial Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2022
• 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: UNSPECIFIED MICROCATHETER.
• Patient Sex: Female