MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 8MM X 35CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF180835
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.(b)(6).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 healthcare professional, during a coil embolization to the internal iliac artery, the physician attempted to detach a 8mm x 35cm deltafill18 coil (dlf180835, l14543) but it was not able to be detached when using a enpower control cable (ecb00018200,l16081).The battery of a control box was full, the green system ready light illuminated, and the beep sound was heard as usual.The detachment button was depressed three times, but the same issue continued.The complaint cable was replaced with another cable, but the same issue continued.The second cable did not successfully detach the coil.The physician replaced the complaint coil with another coil and it detached, there was no report of patient injury.The customer states there is no additional information available.
Additional Manufacturer Narrative
Product complaint #: (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by healthcare professional, during a coil embolization to the internal iliac artery, the physician attempted to detach an 8mm x 35cm deltafill18 coil (dlf180835, l14543) but it was not able to be detached when using an enpower control cable (ecb00018200, l16081).The battery of the control box was full, the green system ready light illuminated, and the beep sound was heard as usual.The detachment button was depressed three times, but the same issue continued.The complaint cable was replaced with another cable, but the same issue continued.The second cable did not successfully detach the coil.The physician replaced the complaint coil with another coil and it detached, there was no report of patient injury.The customer states there is no additional information available.No additional information is available.The device will not be returned for analysis and therefore, no further investigation can be performed at this time.A manufacturing record evaluation was performed for the finished device l14543 number, and no non-conformances related to the reported complaint condition 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 device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.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 devices; 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: DELTAFILL18 8MM X 35CM
• 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: 9401167
• Report Number: 3008114965-2019-01259
• Device Sequence Number: 484627
• Product Code: KRD
• UDI-Device Identifier: 10886704077220
• UDI-Public: 10886704077220
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

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: 11/30/2021
• Device Model Number: DLF180835
• Device Catalogue Number: DLF180835
• Device Lot Number: L14543
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONTROL CABLE.; ENPOWER CONTROL CABLE.