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 Consequences Or Impact To Patient (2199)

Event Date 04/01/2011

Event Type  malfunction  

Event Description

Ascent balloon catheter 4 mm x 7 cm (brs00040700/f38914) burst during correct preparation.

Manufacturer Narrative

Ascent balloon catheter 4 mm x 7 cm (brs00040700/f38914) burst during correct preparation.The length between the proximal seal and the distal seal was 10.0 mm which means that the balloon was over stretched and as a result the unit was damaged.Prior investigations revealed that one of the possible failures when the balloon is over inflated is the occurrence of leaks which, with additional pressure on the balloon, may lead to longitudinal tears.Therefore, the root cause appears to be balloon over inflation.100% leak testing is performed on each balloon catheter before it is release to determine whether the vent hole is open and whether or not the balloon leaks, so it is not likely that the balloon left micrus with a leak or rupture.Complaint was confirmed.A review of the manufacturing records was conducted and no outstanding discrepancies, design, or quality concerns were found.No corrective actions will be taken at this time.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 (SAN JOSE); 821 fox lane; san jose CA 95131
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4104305
• MDR Text Key: 4715843
• Report Number: 1226348-2014-00698
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K080861
• 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: 04/04/2011

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 Catalogue Number: BRS00040700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2011
• Initial Date FDA Received: 09/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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