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

Catalog Number PC410051730

Device Problems Difficult or Delayed Positioning (1157); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2017

Event Type  malfunction  

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 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
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: karen anigbo ; 821 fox lane; san jose, CA 95131 ; 5088288374
• MDR Report Key: 6333999
• MDR Text Key: 67657017
• Report Number: 2954740-2017-00030
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528003014
• UDI-Public: (01)00878528003014(17)200930(10)C38467
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K002056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: PC410051730
• Device Lot Number: C38467
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 02/15/2017
• Date Device Manufactured: 10/19/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1