MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAMAXX - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CDX18052030
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial/final mdr report submitted for this complaint with associated mfr# 2954740-2017-00192.Additional procode: krd (b)(4).Concomitant product: sheath introducer (long sheath), a guidewire (transend, stryker), a guiding catheter (4fr michaelson), a micro catheter (prowler select plus 45°), a y connector (terumo) and an enpower box.Based on the information, the reported event of failure to detach the deltamaxx coil 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.
Event or Problem Description
As reported by a health care professional, during the procedure a deltamaxx coil (cdx18052030/s11694) failed to detach.The procedure was pre-stent grafting coil embolization of an abdominal aortic aneurysm at the lumbar.The patient was a (b)(6)male whose vessel was moderately torturous and mildly calcified.The guiding catheter and the micro catheter were inserted from the right femoral artery and were approached to the lumber artery #3.First coil (deltamaxx 6mm) was inserted and was detached.After which the complaint deltamaxx coil was inserted and the detachment button was pressed but it could not be detached.Box was rebooted and the cable was reconnected but the issue continued although the physician attempted to detach the coil about 4 times.The coil was replaced with another one (same size).The coil embolization was performed at lumbar artery and iia side branches and the procedure was completed with eight micrus coils.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 the 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 investigation.No further information is available.

• Brand Name: DELTAMAXX - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6694595
• Report Number: 2954740-2017-00192
• Device Sequence Number: 11011166
• Product Code: HCG
• UDI-Device Identifier: 10878528008566
• UDI-Public: (01)10878528008566(17)211129(10)S11694
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120274
• 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): 06/19/2017

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: 11/29/2021
• Device Catalogue Number: CDX18052030
• Device Lot Number: S11694
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 07/07/2017
• Patient Sequence Number: 1
• Patient Age: 77