MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 3X6; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX0306
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
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.Date of event: the date of the event was not reported.Procode: krd/hcg.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of three products involved with the complaint and the associated manufacturer report numbers are 3008114965-2021-00396 and 3008114965-2021-00398.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, a 2.5x5 orbit galaxy xtrasoft (640cx2505, 30536893), a 3x6 orbit galaxy xtrasoft (640cx0306, 30383962), and a 2.5x5 orbit galaxy xtrasoft coil (640cx2505, lot unknown) could not detach.There was no patient injury reported.No additional information was reported at the time of the complaint initiation.
Additional Manufacturer Narrative
Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during a coil embolization, a 2.5x5 orbit galaxy xtrasoft (640cx2505, 30536893), a 3x6 orbit galaxy xtrasoft (640cx0306, 30383962), and a 2.5x5 orbit galaxy xtrasoft coil (640cx2505, lot unknown) could not detach.There was no patient injury reported.No additional information is available.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device 30383962 number, 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 of ¿coil ¿ failure to detach¿ could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the events remains speculative and inconclusive, based on the limited information provided and without the return of the complaint devices; however, it is possible that clinical and procedural factors, including device manipulation/interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.Multiple attempts to obtain additional information/product return status were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.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.

• Brand Name: OG CMPLX XTRASOFT COIL 3X6
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 12353866
• Report Number: 3008114965-2021-00397
• Device Sequence Number: 19644632
• Product Code: KRD
• UDI-Device Identifier: 10886704030591
• UDI-Public: 10886704030591
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2021

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: 02/28/2022
• Device Model Number: 640CX0306
• Device Catalogue Number: 640CX0306
• Device Lot Number: 30383962
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OG CMPLX XTRASOFT COIL 2.5X5; OG CMPLX XTRASOFT COIL 2.5X5; OG CMPLX XTRASOFT COIL 2.5X5; OG CMPLX XTRASOFT COIL 2.5X5