MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 10 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	PC410051730
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The presidio will not be returned, therefore the root cause of the positioning and detachment difficulty 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.
Event or Problem Description
The contact from the facility reported that during coil embolization, the presidio coil (pc410051730/c38467) detached after pressing the detach button several times on the enpower dcb.However this resulted in an inaccurate placement of the last loop of the coil as the user moved the microcatheter several times to check if the coil was detached.The last loop of the coil was therefore outside the aneurysm in the parent vessel.The physician tried to push it back into the aneurysm with the microcatheter but was unsuccessful.No further intervention was taken with respect to the coil protrusion.There was no flow restriction as a result.The other coils were detached properly.There was not a significant delay to the procedure as a result of the issue.The coil detached in a few minutes.There were no damages noted to the coil/coil delivery system or detachment system.A pre-deployment electrical check was performed and there was no fault light and the green system ready light illuminated.During the detachment cycle the detachment light illuminated.There was an audible beep at the time of the detachment attempt.All connections appeared to fit properly without use of excessive force.

• Brand Name: PRESIDIO 10 - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6333999
• Report Number: 2954740-2017-00030
• Device Sequence Number: 19235133
• Product Code: HCG
• UDI-Device Identifier: 00878528003014
• UDI-Public: (01)00878528003014(17)200930(10)C38467
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K002056
• 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): 01/24/2017

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: 09/30/2020
• Device Catalogue Number: PC410051730
• Device Lot Number: C38467
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2017
• Initial Report FDA Received Date: 02/15/2017
• Patient Sequence Number: 1