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	11/20/2020
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: 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.
Event or Problem Description
As reported by the field, during a coil embolization, a 1.5mm x 1cm deltaxsft10 coil (dlx100151, l11766) failed to detach after deploying the coil into the aneurysm.There was no patient injury reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this medwatch report: b5, d9, g3, g6, h3, h3, h6 and h10.Section b5: additional information received indicated that the device was not damaged prior to use.Pre-deployment electrical check was performed.The complaint coil was removed from the patient safety and the actual coil was still attached to the coil delivery system.The coil was not stretched or damaged when removed.The procedure was completed by using another coil delivery system.The same cable and datable control box (dcb) were successfully used with subsequent coils.The concomitant device did not have to be removed.No excessive force was applied to the device.Adequate flush was maintained through the devices.There was no prolongation in the procedure due to the event.The treatment was to a saccular aneurysm of the main cerebral artery (mca).Complaint conclusion: as reported by the field, during a coil embolization, a 1.5mm x 1cm deltaxsft10 coil (dlx100151, l11766) failed to detach after deploying the coil into the aneurysm.There was no patient injury reported.Additional information received indicated that the device was not damaged prior to use.Pre-deployment electrical check was performed.The complaint coil was removed from the patient safety and the actual coil was still attached to the coil delivery system.The coil was not stretched or damaged when removed.The procedure was completed by using another coil delivery system.The same cable and datable control box (dcb) were successfully used with subsequent coils.The concomitant device did not have to be removed.No excessive force was applied to the device.Adequate flush was maintained through the devices.There was no prolongation in the procedure due to the event.The treatment was to a saccular aneurysm of the main cerebral artery (mca).A non-sterile unit deltaxsft10 1.5mm x 1cm was received inside of a pouch.The device was inspected, and it was found with several kinks and entangled with itself.Due to the entangled condition noted on the device, the marker band position could not be measure.The embolic coil was inspected under a microscope and it was found mechanically detached with a stretch condition inside the introducer, also, a part of the embolic coil is protruded from introducer.The functional test could not be performed due the conditions in which the device was returned for evaluation.However, the resistance of the device deltaxsft10 1.5mm x 1cm was measured with multimeter.Resistance initially measured approximately 54.4 o, which is within the specification range.Also, the device was connected to detachment control box dcb2000500 (dcb) with an enpower control cable lab sample and the power was turned on.The system ready light was illuminating.These results suggest that the detach cycle was not performed before the mechanical detachment.A manufacturing record evaluation was performed for the finished device l11766 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil - failure to detach¿ could not be evaluated, during the analysis the device was found with several kinks and entangled with itself.During the microscopic inspection, it was noted that the embolic coil was mechanically detached from the rest of the device, a stretch and protruded conditions were observed on the embolic coil.The conditions in which the device was returned could be related with the customer¿s complaint and may have been originated by excessive force and/or handling applied to the device.However, this cannot conclusively be determined, since the exact time when these conditions appear are unknown.Based on the results of the device resistance measurement, the customer complaint cannot be confirmed.Neither the analysis nor the mre suggests that the failure reported by the customer could be related to the 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 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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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: 11163118
• Report Number: 3008114965-2021-00018
• Device Sequence Number: 3526703
• 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,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

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: 02/28/2021
• Device Model Number: DLX100151
• Device Catalogue Number: DLX100151
• Device Lot Number: L11766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 01/13/2021
• 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