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

Catalog Number	CDX18062530
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of one initial/final mdr report being submitted for this complaint with associated mfr# 2954740-2016-00322.(b)(4).The deltamaxx (lot# c39462) will not be returned; therefore the root cause of the non-detachment cannot be determined.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
As reported by a healthcare professional, during coil embolization procedure it was reported that a presidio 18 ((b)(4)) coil was found to be exposed from its sheath and a deltamaxx coil ((b)(4)) failed to detach.The procedure was coil embolization of an arteriovenous malformation at the lung in a (b)(6) female patient whose vessels were not torturous and not calcified.When the presidio18 coil was taken out from its pouch, the micro coil was prematurely exposed approximately 10 cm from the distal tip of the sheath.Therefore the presidio18 was replaced with a new product.Then the deltamaxx coil was inserted into the micro catheter and it was attempted to detach the micro coil; however the coil could not be detached.Therefore the deltamaxx was removed from the patient.It was unknown how the procedure completed.The procedure was completed without further issues or delay.There was also no patient injury / complication reported.The complaint products were 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 products have already been disposed and are 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: 6189096
• Report Number: 2954740-2016-00322
• Device Sequence Number: 13556441
• Product Code: HCG
• UDI-Device Identifier: 10878528008573
• UDI-Public: (01)10878528008573(17)201130(10)C39462
• 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): 12/08/2016

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: 11/30/2020
• Device Catalogue Number: CDX18062530
• Device Lot Number: C39462
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2016
• Initial Report FDA Received Date: 12/20/2016
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICRO CATHETER (PROGREAT, (B)(4))
• Patient Age: 48 YR