MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 3X4; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CX0304
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Section d.2b: procode is krd/hcg.Section e.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Section h.3: 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 review of manufacturing documentation associated with this lot (31025931) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during an endovascular aneurysm embolization procedure, the complaint coil, a 3mm x 4cm orbit galaxy complex xtrasoft coil (640cx0304 / 31025931) was delivered into the concomitant microcatheter (competitor brand) and it passed through the tip of the microcatheter.The physician attempted to detach the coil, but the coil was impeded in the microcatheter tip and could not be detached.The physician retracted the coil and switched to a new coil to complete the procedure using the original microcatheter.There was no report of any negative patient impact.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 07-oct-2023.[additional information]: on 07-oct-2023, additional information was received.Per the information, the gender of the patient is female.The information indicate that the coil was successfully removed from the patient.The reported issue did not result in reduced / restricted blood flow into the parent vessel.The syringe was filled with saline from a dedicated source.The additional information indicated that a new coil was used to complete the surgery, however, information related to whether the same syringe was used to successfully detach coils following the reported issue with the complaint coil could not be obtained.Before attempting to deploy the complaint coil, the syringe reportedly had previously exceeded the green zone / position 3.Prior to the attempt to detach the coil, it was verified under fluoro that there was no stress against the microcatheter or the delivery tube.The coil delivery system was prepped without any difficulty.With the attempt to deploy the coil, the syringe was taken to red alternative detachment zone beyond the green zone after it did not detach in the green zone, ¿it was used according to instructions.¿ the syringe did pressurize as intended when taken to the green zone.Nothing else was done in attempt to detach the complaint coil.The replacement coil was not another 3mm x 4cm orbit galaxy complex xtrasoft coil (640cx0304).The microcatheter used was an echelon¿ 10 microcatheter (medtronic).The information confirmed there was no negative patient impact.There was no clinically significant delay in the procedure as a result of the reported issue.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that multiple attempts to obtain product for analysis were unsuccessful.If product is returned or information provided at a later date, the file will be updated accordingly.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information available and without the complaint product available to be returned for analysis, the reported issue documented in the complaint cannot be confirmed through functional evaluation and analysis.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 3mm x 4cm orbit galaxy complex xtrasoft coil was received contained in the decontamination pouch.Visual inspection was performed.No appearance of damage was observed.The embolic coil was noted to still be attached to the delivery system.The embolic coil component was inspected under the microscope.It was noted that the embolic coil is in good, normal condition (i.E., no elongations, no kinks nor non-concentric loops were noted).The orbit galaxy was attached to a lab sample trufill dcs syringe, then the pressure was increased in the syringe by rotating the syringe knob clockwise until the gauge indicator reach the green zone, in approximately 3 seconds the pressure rapidly decreased indicating that the coil has been successfully detached.The functional test was performed successfully.Additionally, no damages were found on the orbit galaxy that could have contributed to the issue reported during the procedure.The issue reported in the complaint cannot be confirmed with the evidence available.It is possible that other clinical and procedural factors that cannot be replicated during the analysis may have contributed to the reported failure.A review of manufacturing documentation associated with this lot (31025931) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendation: ¿ coil detachment must be confirmed under fluoroscopy by releasing the second rhv and slowly retracting the delivery tube ensuring that the coil is not being retracted into the tip of the infusion catheter and that the delivery tube marker bands move away from the coil without resistance.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 04-dec-2023.A supplemental 3500a report will be submitted once the product investigation has been completed.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: OG CMPLX XTRASOFT COIL 3X4
• 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 ; 303552-6892
• MDR Report Key: 17892473
• Report Number: 3008114965-2023-00693
• Device Sequence Number: 7417957
• Product Code: KRD
• UDI-Device Identifier: 10886704030584
• UDI-Public: 10886704030584
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/11/2023

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: 640CX0304
• Device Lot Number: 31025931
• 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: 09/20/2023
• Supplement Date Received by Manufacturer: 10/07/2023; 11/01/2023; 12/04/2023; 12/11/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 10/09/2023; 11/01/2023; 12/05/2023; 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• 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: ECHELON¿ 10 MICROCATHETER (MEDTRONIC)
• Patient Sex: Female