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

Catalog Number CPL10030430

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2010

Event Type  malfunction  

Event Description

The deltaplush cerecyte microcoil (cpl10020630/ g10951) could not be advanced out of the introducer sheath during preparation, and during product analysis, the coil was found to be severely damaged.Then the connector of another deltaplush cerecyt microcoil (cpl10030430/g11114) did not fit into the connecting cable.

Manufacturer Narrative

(b)(6).This is 1 of 2 mdrs being submitted for patient identifier (b)(6).Complaint conclusion: the electrical connector could be fully plugged into the connecting cable with some friction encountered.No interference was found on the inside cavity walls of the electrical connector.The left and right posts are missing the lead-in chamfer.The electrical connector is missing the lead-in chamfer on the outside edge of the cavity.However, this did not have any effect on inserting the connecting cables plug past this area.There is a out of round condition between the strain relief¿s inside diameter and the electrical connector¿s outside diameter.It was determined that the device positioning unit (dpu) electrical connector pins were misaligned.The most likely root cause of the dpu failure to connect into the enpower control cable was due to the misalignment of the dpu¿s electrical connector¿s posts and the missing lead-in chamfer located at the inside diameter of both electrical posts of the dpu¿s electrical connector.An internal investigation was opened to address this complaint.This mdr is being submitted as part of a retrospective review as the result of a recent fda audit and with accordance to the requirements of code of federal regulations - 21 cfr part 803,.

• Brand Name: DELTAPLUSH - 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 ; 5088283106
• MDR Report Key: 4052670
• MDR Text Key: 4906693
• Report Number: 1226348-2014-00208
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083646
• 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: 09/08/2010

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: 07/19/2015
• Device Catalogue Number: CPL10030430
• Device Lot Number: G11114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2010
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2010
• Initial Date FDA Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2011
• 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