MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF180835
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Procode: krd/hcg.(b)(4).Conclusion: the enpower control cable product and the deltafill product were not returned for investigation.A review of manufacturing documentation associated with these lots presented no issues during the manufacturing or inspection processes related to the reported complaint.The detachment failure could not be confirmed without product return for analysis.The root cause of the event could not be determined based on the information provided.There is no current safety signal identified related to the reported event based on reviews of complaint histories for the devices.Since there was no evidence to suggest the events was related to a manufacturing issues, no corrective actions will be taken at this time.This is an initial/final mdr report.
Event or Problem Description
As reported by a healthcare professional, during coil embolization of a type 2 endoleak at the internal iliac artery, a deltafill18 (dlf180835/ s12542) failed to detach with an enpower control cable (ecb00018200/ s13420).The complaint deltafill18 was used as the first micro coil.The complaint coil was delivered to the lesion and the physician attempted to detach the coil.However, it could not be detached even though the detachment button was pressed.The physician unplugged and connected it for several times, but the issue continued.The complaint enpower control cable was exchanged, but it could not detach the coil.The green system ready light of the enpower control cable illuminated in the beginning.However, after it was unplugged and connected for several times, the light did not illuminate.Therefore, both were replaced to new products and the coil embolization was completed.It was reported that the procedure was completed with the replacement cable.A pre-deployment electrical test had been performed.The procedure was successfully completed without further issues.However, due to the event it was delayed for 10 minutes.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the instruction for use (ifu) and a constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to or after the event.No unintended detachment was observed in the vessel or in the microcatheter.The products have already been disposed and not available for investigation.No further information was available.

• Brand Name: DELTAFILL18
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• MDR Report Key: 6977412
• Report Number: 3013875781-2017-00013
• Device Sequence Number: 1272902
• Product Code: HCG
• UDI-Device Identifier: 10886704077220
• UDI-Public: (01)10886704077220(17)191031(10)S12542
• 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: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: DLF180835
• Device Lot Number: S12542
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 10/25/2017
• Patient Sequence Number: 1
• Patient Age: 60 YR