MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAXSFT10 1.5MM X 1CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLX100151
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
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.Procode: krd/hcg.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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.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a coil embolization, a deltaxsft10 1.5mm x 1cm coil (dlx100151, k10326) failed to detach.With this phenomenon, it was retracted fully and replaced with another coil.There was no surgery delayed due to the reported event.The procedure was successfully completed.No fragments were generated.There was no patient injury reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated section on this medwatch report: b4, b5, e1, e2, e3, g3, g6, h2, h6 and h10.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Section b5: additional information received indicated that a pre-deployment electrical testing was performed.The failure did not occur during pre-deployment electrical check.The same detachable control box (dcb) was used successfully with subsequent coils.The same cable was used successfully with subsequent coils.No neck remodeling was utilized.The coil was still attached to the coil delivery system when removed from the patient.The actual coil was not stretched or damaged when removed.The target vessel/site being treated was the internal carotid artery (ica).No relevant anatomical information including vessel characteristics was reported.No excessive force was applied to the device.The device was removed from the patient without additional intervention.An adequate flush was maintained through the devices.Complaint conclusion: as reported by the field, during a coil embolization, a deltaxsft10 1.5mm x 1cm coil (dlx100151, k10326) failed to detach.With this phenomenon, it was retracted fully and replaced with another coil.There was no surgery delayed due to the reported event.The procedure was successfully completed.No fragments were generated.There was no patient injury reported.Additional information received indicated that a pre-deployment electrical testing was performed.The failure did not occur during pre-deployment electrical check.The same detachable control box (dcb) was used successfully with subsequent coils.The same cable was used successfully with subsequent coils.No neck remodeling was utilized.The coil was still attached to the coil delivery system when removed from the patient.The actual coil was not stretched or damaged when removed.The target vessel/site being treated was the internal carotid artery (ica).No relevant anatomical information including vessel characteristics was reported.No excessive force was applied to the device.The device was removed from the patient without additional intervention.An adequate flush was maintained through the devices.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device k10326 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.Failure to detach is a known potential issue associated with the use of this device.The instructions for use (ifu) contains several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device; 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.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: DELTAXSFT10 1.5MM X 1CM
• 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: 12514945
• Report Number: 3008114965-2021-00471
• Device Sequence Number: 5168731
• Product Code: KRD
• UDI-Device Identifier: 10886704077244
• UDI-Public: 10886704077244
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

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: 11/30/2022
• Device Model Number: DLX100151
• Device Catalogue Number: DLX100151
• Device Lot Number: K10326
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1