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

Catalog Number	CDX18206030
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The deltamaxx will not be returned, therefore the root cause of the coils 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.Procode: krd/hcg.
Event or Problem Description
The contact from the facility reported that during coil embolization of an aneurysm at the right iliac artery the deltamaxx(cdx182060-30/c33979) coil could not be detached.The patient's vessels were mildly torturous and not calcified.There were coils (presidio18/deltamaxx 20mm, azur), a sheath introducer (medkit), a guiding catheter (cerulean g50/g40, medikit), a guidewire (radifocus, terumo), a microcatheter (coiling support, hi-lex corporation) and an enpower control cable and detachment box used for this procedure.A y-connector was not used for the procedure.The procedure was for prophylaxis a type ii endoleak type.An approach was made from the left femoral artery.A guiding catheter and the microcatheter were delivered to the lesion under the sheath.The coil embolization was performed after the tip of the microcatheter was advanced to the lesion.After 2 coils were inserted, the physician inserted the complaint deltamaxx coil and pressed the detachment button but the coil could not be detached.The button was pressed several times but the coil could not be detached.It was confirmed the power light did not turn on.The coil was replaced with another coil (azur, terumo clinical supply) in the same system.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 and after the event.No unintended detachment was observed in the vessel or in the microcatheter.The product was already disposed and 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: 6088251
• Report Number: 2954740-2016-00268
• Device Sequence Number: 16305141
• Product Code: KRD
• UDI-Device Identifier: 10878528008719
• UDI-Public: (01)10878528008719(17)200331(10)C33979
• 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): 10/13/2016

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: 03/31/2020
• Device Catalogue Number: CDX18206030
• Device Lot Number: C33979
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2016
• Initial Report FDA Received Date: 11/08/2016
• Patient Sequence Number: 1
• Patient Age: 88 YR