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

Catalog Number	DLX100152
Medical Device Problem Code	Difficult To Position (1467)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial mdr report being submitted for this complaint with associated mfr# 2954740-2017-00033.Additional pro code: krd.(b)(4).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 or Problem Description
As reported by a health care professional, during the procedure the physician experienced resistance when using a deltaxsft10 1.5mm x 2cm coil and reported that the coil felt stiff when delivered in the aneurysm.The procedure was coiling of anterior communicating artery aneurysm and was reported that the internal carotid artery was very tortuous.The physician had deployed several galaxy coils through the in dwelling catheter.He then tried using the complaint deltaxft10 coil.While advancing the coil through the prowler 14 microcatheter he complained that the delivery system felt ¿stiff¿ and tended to push the catheter (prowler 14) forward.He was able to advance the coil into the aneurysm but while delivering the coil into the aneurysm he then complained that the coil itself felt stiff.He was able to deploy the coil within the aneurysm but the physician was not satisfied with the way the coil was conforming to the walls of the aneurysm.There were no damages noted on the complaint coil or the concomitant devices prior to use or upon removal.An adequate continuous flush was maintained through the catheter.There were no adverse events associated with this incident and no additional medical intervention was required.The complaint product is not available for return.
Additional Manufacturer Narrative
This is final mdr report being submitted for this complaint with associated mfr# 2954740-2017-00033.The deltasft will not be returned, therefore the root cause of the positioning difficulty and the resistance cannot be determined.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.

• Brand Name: DELTAXTRASOFT COIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6338051
• Report Number: 2954740-2017-00033
• Device Sequence Number: 968691
• Product Code: HCG
• UDI-Device Identifier: 10886704077251
• UDI-Public: (01)10886704077251(17)190131(10)C40448R
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2017

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: 01/31/2019
• Device Catalogue Number: DLX100152
• Device Lot Number: C40448R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2017
• Supplement Report FDA Received Date: 03/06/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROWLER 14 MICROCATHETER