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

Catalog Number	CDX18031230
Medical Device Problem Codes	Aborted Charge (2288); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The deltamaxx will not be returned, therefore the root cause of the coil becoming stuck and the sheath damage 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.Common device name: protocode: krd/hcg.
Event or Problem Description
The contact from the facility reported that during coil embolization of a splenic artery at the abdomen the deltamaxx (cdx180312-30/ s10218) was stuck in the microcatheter and the introducer sheath got damaged.The procedure was the coil embolization of a splenic artery at the abdomen.The patient¿s information was unknown.The patient¿s vessels were heavily tortuous.A guidewire (radifocus gt gw, terumo), a microcatheter (sl10, stryker), a y-connector (unknown), and an enpower were also used for this procedure.The complaint coil was inserted, but it got stuck in the micro catheter and the introducer sheath got damaged.It was unknown how the procedure was completed.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 and after the event.No unintended detachment was observed in the vessel or in the micro catheter.The product has already been 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: 6375136
• Report Number: 2954740-2017-00043
• Device Sequence Number: 577978
• Product Code: KRD
• UDI-Device Identifier: 10878528008542
• UDI-Public: (01)10878528008542(17)210331(10)S10218
• 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): 02/03/2017

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: 03/31/2021
• Device Catalogue Number: CDX18031230
• Device Lot Number: S10218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2017
• Initial Report FDA Received Date: 03/02/2017
• Patient Sequence Number: 1