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

Catalog Number BRC00041000

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2010

Event Type  malfunction  

Event Description

During treatment of an intracranial artery, an ascent balloon burst when it was being purged without seeing a drop which indicated a sealing issue.

Manufacturer Narrative

(b)(6).Complaint conclusion: the unit was examined under a microscope to determine whether the contrast media reached the vent hole prematurely, causing the balloon to burst.The vent hole was found to be intact, which indicated that the contrast media never reached it.A longitudinal tear in the balloon was observed, extending from the proximal seal to the distal tip fo the distal marker band.The length of the tear is approximately 14mm.Based on this evidence, the most probably root cause of the complaint is over-inflation of the balloon beyond the limits recommended in the instruction fo ruse (ifu) for this balloon size.The probable root cause of the complaint is over-inflation of the balloon beyond the limits recommended on the ifu for this particular balloon size.For optimum product performance, the balloon must be inflated in accordance with the directions in the ifu.An internal investigation was opened to address this issue.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: 4055945
• MDR Text Key: 4735824
• Report Number: 1226348-2014-00237
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K080861
• 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: 10/27/2010

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2011
• Device Catalogue Number: BRC00041000
• Device Lot Number: F38830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2010
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2010
• Initial Date FDA Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2010
• 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
• Patient Age: 50 YR