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

Catalog Number	CDX18104030
Medical Device Problem Codes	Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial mdr report submitted for this complaint with associated mfr# 2954740-2017-00209.(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.
Event or Problem Description
As reported by a healthcare professional, during the procedure resistance was experienced with the microcatheter when using a deltamaxx coil (cdx18104030/c36983), the coil also unraveled during the procedure.The procedure was dural-arterio venous fistulae (tve) coil embolization of an aneurysm at the transverse sigmoid sinus.A micro catheter was approached to the sinus from the jugular vein.When deltamaxx coil (complaint product) was inserted, there was strong resistance felt, so it was withdrawn into the micro catheter however there was still resistance felt.The coil had unraveled.The coil and the micro catheter were removed successfully.The coil was replaced with competitive one.More than half of the deltamaxx coil was placed in the blood vessel, so the coil unraveling occurred either inside the micro catheter or inside the blood vessel.There was no resistance between the guidewire and the microcatheter when accessing the target site.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.
Additional Manufacturer Narrative
This is final mdr report submitted for this complaint with associated mfr# 2954740-2017-00209 based on the information, the event could not be confirmed.The deltamaxx coil 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 events based on review of complaint history for the device.

• 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: 6722703
• Report Number: 2954740-2017-00209
• Device Sequence Number: 13499465
• Product Code: HCG
• UDI-Device Identifier: 10878528008610
• UDI-Public: (01)10878528008610(17)200731(10)C36983
• 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,Followup
• Report Date (Section B): 06/28/2017

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: 07/31/2020
• Device Catalogue Number: CDX18104030
• Device Lot Number: C36983
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2017
• Supplement Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 08/21/2017
• Patient Sequence Number: 1