MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL MICROCOIL DELIVERY SYSTEM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number DLF182060

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2017

Event Type  malfunction  

Manufacturer Narrative

This is initial mdr report being submitted with associated mfr # 2954740-2017-00189.Additional procode: krd.(b)(4).Concomitant products: enpower cable: ecb00018200; detachment control box dcb00000500.(b)(6).The product will not be returned for analysis however a device history record review is currently being conducted and the results are not yet available.No conclusion is made at this time.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, detachment issue was experienced when using a deltafill18 20mm x 60cm coil (dlf182060/s12428).The procedure was embolization of an anterior communicating artery aneurysm.The coil did not detach after four attempts and on the fifth attempt the coil detached in the microcatheter end.It was reported that a pre-deployment check was performed; upon pressing the power button all lights illuminate and the green system ready light illuminated.During the detachment cycle, the detachment light illuminated and the audible signal beeped.All connections appeared to fit properly without application of excessive force.The same dcb and the connecting cable were used with subsequent coils.No patient consequence was reported due to the event.It was initially reported that the complaint product is not available for return.

Manufacturer Narrative

This is final mdr report being submitted with associated mfr# 2954740-2017-00189.Based on the information, the event could not be confirmed.The product was not returned for analysis; however, a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.There is no current safety signal identified related to the reported event based on review of complaint history for the device.

• Brand Name: DELTAFILL MICROCOIL DELIVERY SYSTEM
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: karen anigbo ; 821 fox lane; san jose, CA 95131 ; 5088288374
• MDR Report Key: 6674016
• MDR Text Key: 78905283
• Report Number: 2954740-2017-00189
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10886704077169
• UDI-Public: (01)10886704077169(17)190930(10)S12428
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K150319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: DLF182060
• Device Lot Number: S12428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2017
• Initial Date FDA Received: 06/28/2017
• Supplement Dates Manufacturer Received: 08/03/2017
• Supplement Dates FDA Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1