MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 2.5X5; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CX2505
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section b3 ¿ date of event: the date of the event was not reported.Section h3 - the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.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 a coil embolization to an aneurysm at the basilar tip, an orbit galaxy xtrasoft coil (640cx2505, 31025935) would not detach.The coil was removed and another brand of coils was selected.The surgery was successfully completed.There was no patient injury reported.The surgery was delays by 4 minutes due to the event, the delay was not clinically significant.The same trufill dcs syringe ii (635002, 96331437) was no used to detach the subsequent coils.The syringe had previously exceeded the green zone/position 3.After the coil did not detach at the syringe green zone, it was attempted to deploy the coil at the syringe red alternative detachment zone.It is unknown if prior to attempting to detach, if it was verified under fluoro that there was no stress against the microcatheter or delivery tube.The syringe lost some pressure once taken up to green and red.May have been a leak in the system but unknown culprit.Neck remodeling was utilized if an atlas stent.It was not t necessary to remove the microcatheter with the coil.The coil was coil still attached to the coil delivery system when removed from the patient.Approach from right vertebral artery.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complaint conclusion¿ as reported by the field, during a coil embolization to an aneurysm at the basilar tip, an orbit galaxy xtrasoft coil (640cx2505, 31025935) would not detach.The coil was removed and another brand of coils was selected.The surgery was successfully completed.There was no patient injury reported.The surgery was delays by 4 minutes due to the event, the delay was not clinically significant.The same trufill dcs syringe ii (635002, 96331437) was no used to detach the subsequent coils.The syringe had previously exceeded the green zone/position 3.After the coil did not detach at the syringe green zone, it was attempted to deploy the coil at the syringe red alternative detachment zone.It is unknown if prior to attempting to detach, if it was verified under fluoro that there was no stress against the microcatheter or delivery tube.The syringe lost some pressure once taken up to green and red.May have been a leak in the system but unknown culprit.Neck remodeling was utilized if an atlas stent.It was not t necessary to remove the microcatheter with the coil.The coil was still attached to the coil delivery system when removed from the patient.Approach from right vertebral artery.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 31025935number, and no non-conformances related to the malfunction were identified.With the information available and without the product available for analysis, the reported customer complaint 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.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.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.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Updated sections on this medwatch: b3, b4, g3, g6, h2 and h10.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: OG CMPLX XTRASOFT COIL 2.5X5
• 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. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18029465
• Report Number: 3008114965-2023-00781
• Device Sequence Number: 12240646
• Product Code: KRD
• UDI-Device Identifier: 10886704030652
• UDI-Public: 10886704030652
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2023

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 Catalogue Number: 640CX2505
• Device Lot Number: 31025935
• 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: 10/12/2023
• Supplement Date Received by Manufacturer: 11/14/2023; 12/14/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 11/14/2023; 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: TRUFILL DCS SYRINGE II
• Patient Age: 78 YR
• Patient Sex: Female