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

Catalog Number	CPL10020230
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of two initial/final mdr report being submitted for this complaint with associated mdr report 2954740-2016-00196.(b)(4).The deltaplush coil will not be returned, therefore the root cause of the coil's failure to detach 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.Since there was no evidence of a manufacturing issue related to the event, no corrective action will be taken at this time.
Event or Problem Description
As reported by a health care professional, during an emergency coil embolization of an aneurysm for hemoptysis two deltaplush (cpl100202-30/c36701) coils failed to detach.The patient's gender and age were unknown; the level of tortuousness and calcification of the vessels were also unknown.A 4fr system with 45 degree microcatheter (competitor's) was used for the procedure.A pre-deployment electrical check was performed indicating no issues with the power supply.When the physician attempted to detach the complaint deltaplush coils after placement, the audible signal beeped however the coils did not detach.The coils were collected as defective.The procedure was successfully completed without further issues and delay.There were no patient injuries or complications reported.All connections appear to fit properly without application of excessive force.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 times.No visible defect or 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 complaint products have already been disposed and not available for investigation.No further information is 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: 5913466
• Report Number: 2954740-2016-00195
• Device Sequence Number: 13553785
• Product Code: HCG
• UDI-Device Identifier: 00878528008217
• UDI-Public: (01)00878528008217(17)200630(10)C36701
• 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): 08/23/2016

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: 06/30/2020
• Device Catalogue Number: CPL10020230
• Device Lot Number: C36701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2016
• Initial Report FDA Received Date: 08/30/2016
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE (GT12) MICROCATHETER (SL10)