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

Catalog Number BRS00040700

Device Problem Burst Container or Vessel (1074)

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

Event Date 02/28/2011

Event Type  malfunction  

Event Description

This ascent balloon burst during preparation.The standard prep procedure was mostly used with 2 negative aspirations using a sub-filled 20cc syringe to remove air (this was done with the balloon tip in 70:30 contrast mix).Upon switching to a 1cc syringe, air was seen to mostly be filling the balloon and, when the physician attempted to force the air from the balloon and generate a contrast bubble, the balloon burst.Another ascent balloon was used to effectively remodeling the anterior communicating artery aneurysm.There was no serious injury or required intervention as a result of the event.

Manufacturer Narrative

(b)(6).Complaint conclusion: the device was returned for analysis.No defects were found during the inspection of the outer surface of the catheter except for a longitudinal tear of 11mm on the balloon, extending from the proximal seal to the distal seal.This is an indication that the balloon was over inflated, which resulted in stretching the balloon and the subsequent rupture.A review of the manufacturing documentation found no issues related to the complaint.The burst was confirmed.The longitudinal tear along the length of the balloon indicates that it was over stretched during inflation.Step 4 of the product instructs for use (ifu) includes a warning against exceeding the maximum inflation volume.The ifu also includes a table listing the recommended inflation volumes for each balloon size.Since there were no manufacturing issues determined to be related to the complaint, 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: 4060602
• MDR Text Key: 4860704
• Report Number: 1226348-2014-00355
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/28/2011

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: 04/12/2011
• Device Catalogue Number: BRS00040700
• Device Lot Number: F38881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2011
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2011
• Initial Date FDA Received: 09/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2010
• 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: 70 YR