MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 16MM X 50CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF181650
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This initial/final mdr will be the only report submitted for mfr report #3008114965-2018-00571.Product code: krd/hcg.Concomitant medical product: dcb ((b)(4)), microcatheter (prowler select plus), enpower.(b)(6).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.A non-conformance was generated because outer diameter (od) of the resistance heating (rh) coil assembly was not inspected during product final inspection.A health hazard evaluation concluded that the primary risk of the rh coil od being out of specification is that the end user would experience friction while advancing or retracting the device through a microcatheter.In addition, statistical evaluation in the hhe indicated that product in the field should be within specification, even though the required inspection was not conducted.Based on the results of the hhe product was released as acceptable.There are no current safety signals for this lot number, product, or issue.All product rejected during manufacturing was identified as scrap and properly accounted for.
Event or Problem Description
It was reported by a healthcare professional that a deltafill 18 coil ((b)(4)) could not be detached during a coil embolization procedure of an aneurysm for evar at the iia.It was reported that an energization failure occurred.Therefore, the coil was replaced with another one.The patient was a (b)(6)-year-old male whose vessel was not torturous and not calcified.A dcb ((b)(4)), microcatheter (prowler select plus), and an enpower were also used for this procedure.The procedure was successfully completed without further issues or delay.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 ifu and a constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.The product is not available for the investigation.No further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up mdr will be the only report submitted for mfr report #3008114965-2018-00571.Additional information received on march 29, 2018: (b)(6).
Additional Manufacturer Narrative
Product complaint # (b)(4).This follow-up mdr will be the only report submitted for mfr the initial report.This mdr is being submitted to report the following additional information that was received on june 04, 2018: the patient was a 75-year-old male.No damage was noted to the device prior to the procedure.

• Brand Name: DELTAFILL18 16MM X 50CM
• 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: 7334330
• Report Number: 3008114965-2018-00571
• Device Sequence Number: 16301765
• Product Code: KRD
• UDI-Device Identifier: 10886704077145
• UDI-Public: 10886704077145
• Combination Product (Y/N): N
• 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,Followup,Followup
• Report Date (Section B): 03/29/2018

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: 09/30/2019
• Device Catalogue Number: DLF181650
• Device Lot Number: S12208
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 03/29/2018; 06/04/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 04/26/2018; 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR