MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC ASCENT - BALLOON CATHETER; CES BALLOON CATHETER

Catalog Number BRC00041500

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2011

Event Type  malfunction  

Event Description

An ascent balloon was found to have developed a leak during the prep.During product analysis it was determined that the balloon had burst.

Manufacturer Narrative

(b)(6).Complaint conclusion: the balloon catheter, as received from the field, showed evidence of having burst.Due to the rupture, it was not possible to investigate the balloon for leaks.The only defect found during the catheter outer surface inspection of the balloon area was a longitudinal tear of 20mm from the proximal seal to the distal seal.This finding indicates that the balloon was over inflated resulting in stretching of the balloon, which in turn led to the rupture.The root cause appears to be balloon over inflation.One of the possible failures when the balloon is over inflated is balloon leakage.Additional pressure on the balloon may further lead to longitudinal tears.The instructions for use (ifu) for the ascent balloon catheter caution against over expanding the balloon, and an inflation guide is also provided to the ifu for reference.Codman performs 100% leak testing on each lot of balloon catheters before release to distribution; therefore, it is unlikely that the balloon was shipped in this condition.No corrective action was taken.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: ASCENT - BALLOON CATHETER
• Type of Device: CES BALLOON CATHETER
• 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: 4056752
• MDR Text Key: 4863324
• Report Number: 1226348-2014-00261
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/03/2011

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: 06/17/2011
• Device Catalogue Number: BRC00041500
• Device Lot Number: F38911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2011
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2011
• Initial Date FDA Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2010
• 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