MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAXSFT10 2MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLX100206
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization, a deltaxsft10 2mm x 6cm coil (dlx100206, 30921357) could not be removed from hoop / strong resistance occurred, so physician did not pull any further.Other cnv coils were used to finish the procedure.Based on additional information received on 10-apr-2024, the coil was separated from dpu, dpu wire appeared stretched.The remainder of the coil will be returned for inspection.There was no patient injury as the device was not clinically used.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
Additional Manufacturer Narrative
Product complaint (b)(4) 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).Updated sections on this medwatch: b4, g3, g6, h2, h3, h6 and h11.Complaint conclusion.As reported by the field, during a coil embolization, a deltaxsft10 2mm x 6cm coil (dlx100206, 30921357) could not be removed from hoop / strong resistance occurred, so physician did not pull any further.Other cnv coils were used to finish the procedure.Based on additional information received on 10-apr-2024, the coil was separated from dpu, dpu wire appeared stretched.The remainder of the coil will be returned for inspection.There was no patient injury as the device was not clinically used.A non-sterile deltaxsft10 2mm x 6cm was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was noted that only the coil was returned for evaluation.Under magnification, the embolic coil was found to be severely stretched on the proximal portion and broken.The issue regarding a coil being separated from dpu was confirmed based on the appearance of the returned component.Stretching can occur during procedure handling where force may have been inadvertently applied, which ultimately results in the coil being broken and separated from the unit.Coil stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.There is no indication that the issue reported is a result of a defect inherently related to the device.The issue regarding a device being difficult to remove from the dispenser hoop and a dpu being stretched cannot be evaluated.With the limited information and the lack of the returned components, a functional test cannot be performed and a conclusive cause of the failure cannot be determined; however, it is possible that clinical and procedural factors, including device manipulation and operator's technique, may have contributed to the reported failure.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Therefore, no capa activity is required.A manufacturing record evaluation was performed for the finished device 30921357 number, and no non-conformances related to the malfunction were identified.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) contain the following precautions: do not bend the dpu wire as the device is pulled from the packaging hoop as this may result in damage to the device.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 2MM X 6CM
• 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: 19126925
• Report Number: 3008114965-2024-00409
• Device Sequence Number: 7647363
• Product Code: KRD
• UDI-Device Identifier: 10886704077336
• UDI-Public: 10886704077336
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2024

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: 09/30/2025
• Device Catalogue Number: DLX100206
• Device Lot Number: 30921357
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 04/29/2024; 05/30/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 05/20/2024; 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2022
• 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