MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAXSFT10 4MM X 8CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLX100408
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
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 d2b ¿ procode: krd/hcg.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.The company is seeking this information through the event investigation.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, a deltaxsft10 4mm x 8cm coil (dlx100408, 30784459) did not detach.There was no patient injury reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this medwatch: b4, b5, e1, e3 g3, g6, h2 and h10.Additional event information was received on 16-may-2024 indicating that pre-deployment electrical testing was performed.The same dcb and cable were used successfully with subsequent coils.The deltaxsft10 4mm x 8cm coil was removed from the patient and the procedure was completed with another cnv coil.There was no patient injury reported.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: b4, d9, g3, g6, h2, h3 and h11.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).Complaint conclusion: as reported by the field, during a coil embolization, a deltaxsft10 4mm x 8cm coil (dlx100408, 30784459) did not detach.There was no patient injury reported.Additional event information was received on 16-may-2024 indicating that pre-deployment electrical testing was performed.The same dcb and cable were used successfully with subsequent coils.The deltaxsft10 4mm x 8cm coil was removed from the patient and the procedure was completed with another cnv coil.There was no patient injury reported.A non-sterile deltaxsft10 4mm x 8cm was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was noted that the coil was outside of the introducer.No other damages were found.The device was inspected under microscopic magnification, and the embolic coil was found still attached to the resistance heating (rh).The distal outer sheath had not been softened, indicating that the detachment process was not initiated.The electrical resistance of the device was measured with a multimeter, it measured 53.4 ohms o, which is within the specification range.Also, the device was connected to a lab sample detachment control box (dcb), and a lab sample enpower control cable, and the power was turned on.The system ready light was illuminating.Then, the detach button was pressed, and a beep sound was heard.The coil was successfully detached from the unit.The issue documented that the coil failed to detach could not be confirmed since the device met the electrical specification range.Additionally, no product defect was identified; there may have been other circumstances or issues that occurred during the use of the device that could not be replicated in the lab setting.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.According to the risk documentation, failure to detach is a potential issue that can occur during the coil detachment due to a detachment cycle not being initiated, as a result of the dpu wire detachment zone/extended coil being positioned beyond the microcatheter tip, which can result in reported failure.A manufacturing record evaluation was performed for the finished device 30784459 number, and no non-conformances related to the malfunction were identified.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Therefore, no capa activity is required.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendation: ¿ verify that the microcoil delivery system is fully connected, and no faults are indicated on the dcb.If a fault exists, reseat all connections between the dpu, the dcb, and the connecting cable.If a fault still persists, replace the connecting cable.If this does not correct the error, replace the dcb.If the microcoil delivery system still continues to have a fault, retrieve the microcoil, re sheathing the microcoil system, and replace it with a new 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: DELTAXSFT10 4MM X 8CM
• 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: 19259186
• Report Number: 3008114965-2024-00476
• Device Sequence Number: 11408596
• Product Code: KRD
• UDI-Device Identifier: 10886704077374
• UDI-Public: (01)10886704077374(11)220425(17)250331(10)30784459
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/22/2024

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: 03/31/2025
• Device Catalogue Number: DLX100408
• Device Lot Number: 30784459
• 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: 04/25/2024
• Supplement Date Received by Manufacturer: 05/16/2024; 06/03/2024; 07/19/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 05/16/2024; 06/04/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2022
• 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
• Patient Sex: Unknown