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

Catalog Number	CDX18052030
Medical Device Problem Codes	Positioning Failure (1158); Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The deltamaxx will not be returned, therefore, the root cause of the wire kinking and the non detachment cannot be determined.Dhr: 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.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.Therefore, no corrective actions will be taken at this time.
Event or Problem Description
The contact from the facility reported that during coil embolization of an aneurysm at the hepatic artery, the delivery wire of the deltamaxx coil (cdx180520-30/ c36979) was kinked and the coil did not detach.The patient¿s information was unknown.The patient¿s vessel level of tortuousness and calcification were unknown.A delivery wire of the deltamaxx was inserted into the patient and it got kinked.The delivery wire was held by a forceps to advance.However the green system ready light did not illuminate with the complaint coil and no sound was heard when the deployment button was pressed.Therefore it was replaced with a new micro coil.In this procedure, eight micro coils were implanted in total.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 times.No visible defect/damage was noted on the products prior to and after the event.No unintended detachment was observed in the vessel or in the micro catheter.The product is not available for the 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: 6199854
• Report Number: 2954740-2016-00326
• Device Sequence Number: 18976509
• Product Code: KRD
• UDI-Device Identifier: 10878528008566
• UDI-Public: (01)10878528008566(17)200731(10)C36979
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2016

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: CDX18052030
• Device Lot Number: C36979
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2016
• Initial Report FDA Received Date: 12/22/2016
• Patient Sequence Number: 1