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

Catalog Number	CPL10015330
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion: the device was not returned for analysis.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.The failure to detach the coil could not be confirmed without product return for analysis.Based on the information provided, it is not possible to determine the cause of the issue or what factors may have contributed to the event.There was no evidence to suggest the event was related to a manufacturing issue; therefore, no corrective actions will be taken at this time.This is an initial/final mdr report.
Event or Problem Description
As reported by a healthcare professional, during coil embolization for a type 2 endoleak, the green system ready light did not illuminate and the deltaplush coil (cpl10015330/ s11306) could not be used.The sl-10 microcatheter was approached to the feeder artery.The deltaplush was connected to the cable, but the green system ready light did not illuminate.The coil was replaced with another one.The procedure was successfully completed without further issues or delay.It was unknown if a pre-deployment electrical check was performed.There was 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 or after the event.No unintended detachment was observed in the vessel or in the microcatheter.The product was not available for investigation.No further information was available.

• Brand Name: DELTAPLUSH - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6390816
• Report Number: 2954740-2017-00050
• Device Sequence Number: 759704
• Product Code: HCG
• UDI-Device Identifier: 00878528008194
• UDI-Public: (01)00878528008194(17)210731(10)S11306
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083646
• 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): 02/13/2017

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: 07/31/2021
• Device Catalogue Number: CPL10015330
• Device Lot Number: S11306
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2017
• Initial Report FDA Received Date: 03/09/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER (SL-10, STRYKER)