MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT HEL 2MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLX120206
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.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)(4).Section d2b ¿ procode: krd/hcg section e1.Initial reporter phone: (b)(6) the device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.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.
Event or Problem Description
As reported by the field, during an endovascular embolization, a galaxy g3 xsft hel 2mm x 6cm coil (glx120206, 30803130) was impeded at the distal end of the microcatheter (other brand) and could not pass through the microcatheter (mc).The coil was found unraveled/stretched.The physician retracted the coil out of the patient and switched a new coil to detach it successfully at the target site.Then the physician delivered an enterprise2 4mmx16mm intracranial stent (encr401612, 8337178) to the target site and started to release it, 3 distal markers of the stent were converged which could not expand as expected.The physician retracted the stent out of the patient¿s body and replaced it with a new stent to complete the procedure.The coiling microcatheter and the stenting microcatheter were not replaced.There was no patient injury reported.Additional event information received on 22-may-2024 indicated that they were not able to move the coil at all.They were not able to move the coil at all due to the resistance.There was no evidence of physical material within the device.It is possible that excessive force was used with the coil.There was difficulty removing the coil from the patient.Prior to this coil, other coils were able to be advanced through the same microcatheter.There was no blood flow restriction/reduction as a result of the event.The temperature indicator label on the inner pouch of the stent has been checked and found to be within acceptable criteria.There was no apparent damage to the stent.There were vessel or aneurysm factors that may have contributed to the incomplete expansion.No additional intervention was performed to attempt to expand the stent.There were no procedural delays due to the events.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complaint conclusion: as reported by the field, during an endovascular embolization, a galaxy g3 xsft hel 2mm x 6cm coil (glx120206, 30803130) was impeded at the distal end of the microcatheter (other brand) and could not pass through the microcatheter (mc).The coil was found unraveled/stretched.The physician retracted the coil out of the patient and switched a new coil to detach it successfully at the target site.Then the physician delivered an enterprise2 4mmx16mm intracranial stent (encr401612, 8337178) to the target site and started to release it, 3 distal markers of the stent were converged which could not expand as expected.The physician retracted the stent out of the patient¿s body and replaced it with a new stent to complete the procedure.The coiling microcatheter and the stenting microcatheter were not replaced.There was no patient injury reported.Additional event information received on 22-may-2024 indicated that they were not able to move the coil at all.They were not able to move the coil at all due to the resistance.There was no evidence of physical material within the device.It is possible that excessive force was used with the coil.There was difficulty removing the coil from the patient.Prior to this coil, other coils were able to be advanced through the same microcatheter.There was no blood flow restriction/reduction as a result of the event.The temperature indicator label on the inner pouch of the stent has been checked and found to be within acceptable criteria.There was no apparent damage to the stent.There were vessel or aneurysm factors that may have contributed to the incomplete expansion.No additional intervention was performed to attempt to expand the stent.There were no procedural delays due to the events.A non-sterile deltapaq cere 1.5mmx2cm coil was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was noted that the coil was returned inside the introducer.Under magnification, the embolic coil was found to be severely stretched and it was noted that as a result of the stretching the internal blue fiber was exposed.However, this remains attached to the resistance heating (rh), which was noted to be not softened.No other damages were noted in the device.The issue documented a coil that was impeded at the distal end of the microcatheter was confirmed based on the appearance of the returned device.The stretched damage observed in the coil was the result of the impeded condition experienced during the procedure that could not be replicated in the laboratory.Stretching can occur during procedure handling where force may have been inadvertently applied.According to the risk documentation, friction and difficulty to advance are potential issues that can occur during microcoil placement due to continuous saline flush not being established, which can result in coil stretching.Coil stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.There is no indication that the issue reported is a result of a defect inherently related to the device.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Therefore, no capa activity is required.A manufacturing record evaluation was performed for the finished device 30803130 number, and no non-conformances related to the malfunction were identified.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) contain the following precautions: if unusual friction is noticed during advancement or retraction of the microcoil system through the introducer, open the rhv main valve, and partially withdraw the distal end of the introducer to expose its tip within the rhv.Tighten the rhv main valve and flush the y-connector of the rhv with sterile saline and verify that fluid exits the slit in the clear portion of the introducer.If unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw and examine the delivery catheter system.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.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 XSFT HEL 2MM X 6CM
• 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): CERENOVUS INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19382413
• Report Number: 3008114965-2024-00521
• Device Sequence Number: 6342190
• Product Code: KRD
• UDI-Device Identifier: 10886704077756
• UDI-Public: 10886704077756
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2024

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: 04/30/2025
• Device Catalogue Number: GLX120206
• Device Lot Number: 30803130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 06/06/2024; 06/12/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 06/07/2024; 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2022
• 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: COILING MICROCATHETER (UNSPECIFIED BRAND)
• Patient Sex: Unknown