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

Catalog Number HEL10020220

Device Problems Partial Blockage (1065); Device-Device Incompatibility (2919)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2010

Event Type  malfunction  

Event Description

The helipaq 10 platinum microcoil could not be connected to the cable, and during product analysis, adhesive was found on the device positioning unit's (dpu) top surface.There was no serious injury or intervention required.

Manufacturer Narrative

(b)(6).Complaint conclusion: the helipaq device was returned for analysis; however, the connection cable was not returned.It was confirmed that the dpu¿s electrical connector could not fit into the connecting cable.Adhesive was found on the complete top surface.Adhesive was also found down inside the cavity with the left side having adhesive almost to the top of the electrical post.The right side had a minimal amount of adhesive.There were no other anomalies found on this part that could be complaint related.The most likely root cause of the device positioning unit¿s (dpu) electrical connector not being able to be connected to the connecting cable was due to adhesive found inside the cavity.The circumstances of how and where this adhesive was deposited into the electrical connector¿s cavity cannot be determined.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.

• 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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4056753
• MDR Text Key: 4904087
• Report Number: 1226348-2014-00262
• 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,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/17/2010

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: 01/22/2015
• Device Catalogue Number: HEL10020220
• Device Lot Number: F32243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2011
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2010
• Initial Date FDA Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2007
• 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