MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FRAME COIL 7X25; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CR0725
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
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.Procode: krd/hcg initial reporter phone: (b)(6).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.The company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2021-00001 and 3008114965-2021-00001.
Event or Problem Description
As reported by the field, during a coil embolization, it was reported that the coil of a 7x25 og tdl cmplx frame coil (640cr0725, 30396175) cannot be formed after push-out.It was reported that the coil cannot be formed after push-out.The physician changed the device to a 4x8 og cmplx xtrasoft coil (640cx0408, 30345369) and the same problem happened.The physician changed to another new one to complete the procedure.There was not patient injury report.
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, it was reported that the coil of a 7x25 og tdl cmplx frame coil (640cr0725, 30396175) cannot be formed after push-out.The physician changed the device to a 4x8 og cmplx xtrasoft coil (640cx0408, 30345369) and the same problem happened.The physician changed to another new one to complete the procedure.There was not patient injury report.No additional information is available.A non-sterile unit og tdl cmplx frame coil 7x25 was received inside of a pouch.The device was inspected, and it was found in good normal conditions, no damages or anomalies were observed during the analysis.The device was inspected under a microscope and it was found that the embolic coil is separated from gripper inside the introducer, although the embolic coil was found separated from gripper no damages or anomalies were observed on it.A manufacturing record evaluation was performed for the finished device 30396175 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil - positioning difficulty-poor conformability¿ could not be duplicated because the complaint reported by the customer is specific to the patient and procedure at the time of occurrence and cannot be replicated in the lab.Initially, during the microscopic analysis, the embolic coil was inspected, and it was found in good normal conditions.However, further, along with the analysis, the embolic coil was found separated from gripper.This condition is not related with the customer¿s complaint regarding poor conformability.This condition could be originated due excessive force and/or handling applied to the device during the procedure time, therefore the event reported was not confirmed.Neither the analysis nor the mre suggests that the failure reported by the customer could not be related to the manufacturing process.The instructions for use (ifu) instructs on proper positioning of the microcoil system.The ifu also warns: ¿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¿.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned 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.

• Brand Name: OG TDL CMPLX FRAME COIL 7X25
• 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: 11109393
• Report Number: 3008114965-2021-00001
• Device Sequence Number: 17124137
• Product Code: KRD
• UDI-Device Identifier: 10886704030447
• UDI-Public: 10886704030447
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

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: 04/30/2022
• Device Model Number: 640CR0725
• Device Catalogue Number: 640CR0725
• Device Lot Number: 30396175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 02/02/2021
• 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 4X8