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

Catalog Number HEL10020420

Device Problems Electrical /Electronic Property Problem (1198); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2010

Event Type  malfunction  

Manufacturer Narrative

The coil failed the resistance test and the enpower green system go light did not illuminate.Passes continuity test.The coil was returned unsheathed and unprotected.The detachment fiber did not receive heat and melt.Tension was applied and manipulation of the microcoil system failed to change the resistance reading.The most likely root cause of the non-detachment was due to wiring damage or an incomplete solder joint in the resistive heating coil.The exact source of this damage can not be determined.For optimal product use, it is recommended that a pre-deployment electrical test be performed before use.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, medical device reporting.

Event Description

After the coil was placed at the pulmonary artery; it was connected to the cable.Line error light was on.Though it was replaced by the old control box; the error light remained on.There was no problem when it was done with a new coil.

• Brand Name: HELIPAQ 10 - PLATINUM 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 (SAN JOSE); 821 fox lane; san jose CA 95131
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4064274
• MDR Text Key: 19371983
• Report Number: 1226348-2014-00374
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/31/2010

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2016
• Device Catalogue Number: HEL10020420
• Device Lot Number: F31014
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2010
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1