MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC PRESIDIO 10 - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number PC410062630

Device Problems Misconnection (1399); Delivery System Failure (2905)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2014

Event Type  malfunction  

Event Description

During coil embolization of a vertebral artery aneurysm, it was noted that the physician could not detach a presidio (pc4100626-30/c17506, complaint product) although pressing the detachment button.The green system ready light illuminated at the time the detachment was attempted.The enpower detachment control box (dcb000005-00, lot unknown) and an unspecified cable (catalogue and lot unknown) were used with the product.Then, when he replaced the presidio for a new product (pc4100626-30, lot unknown), he was able to detach it using the same detachment control box and cable with no further issues.Afterwards, the procedure was successfully completed without any further issues.There was no patient injury/complications reported.The product was new and stored per labeling instructions.The procedure was conducted in accordance with the (instructions for use (ifu) and a constant flush had been maintained at all times.Prior to use, no defect (kink, bends etc) was noted on the product by visual inspection.Also no damages were reported on the device after the event.Pre-deployment electrical check was performed and no issues were noted.All connections appeared to fit properly.There was no stretching or unintended detachment observed in the aneurysm or in the microcatheter (excelsior sl10/stryker, type str).The complaint product is unavailable for evaluation.No additional information is available.

Manufacturer Narrative

(b)(4).Information about patient age, weight, and concomitant medications were not provided.Complaint conclusion: the device was not available 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 detachment failure could not be confirmed since the device was not returned for analysis.Based on the information provided, the root cause of the failure, as well as factors that may have contributed to the failure, could not be determined.Since there were no issues related to the failure found in the manufacturing documentation, and there is no evidence to suggest there was a manufacturing issue related to the failure, no corrective actions will be taken at this time.This is an initial/final mdr.

• Brand Name: PRESIDIO 10 - CERECYTE MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): MICRUS ENDOVASCULAR, LLC; 821 fox lane; san jose CA 95131
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014
• MDR Report Key: 3804254
• MDR Text Key: 4366669
• Report Number: 1226348-2014-00105
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2018
• Device Catalogue Number: PC410062630
• Device Lot Number: C17506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1