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 09/07/2011

Event Type  malfunction  

Event Description

The complaint received states that during use the ascent balloon catheter 4 mm x 10 cm (brc00041000 / f61157) burst.Ascent balloon had a hole in it and was detected during preparation.There is no report of injury for the patient.

Manufacturer Narrative

This mdr is being submitted as part of retrospective review as a result of a recent fda audit and with accordance to the requirements of code of federal regulations ¿ 21 cfr part 803, medical device reporting.The complaint received states that during use the ascent balloon catheter 4 mm x 10 cm (brc00041000 / f61157) burst.Ascent balloon had a hole in it and was detected during preparation.There is no report of injury for the patient.Although no kinks were found on the catheter, the length of the proximal seal and the distal deal measured 15.0mm which occurs when the balloon was over stretched causing the catheter to become damaged.A pinhole leak was found in the balloon area.The investigation showed a pin hole between both marker bands.The root cause appears to be over inflation.There was no additional damage around the pin hole.A 100% leak test is performed on each balloon before it is released to determine whether any leaks are present, so it is not likely that the balloon left micrus in this condition.The complaint was confirmed on analysis.100% inspections are in place to prevent damaged products from leaving the facility and the dhr review confirmed that the product met specifications.No corrective action is required at this time.Review of the information suggests that procedural factors may have contributed to the confirmed failure.

• 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: 4070199
• MDR Text Key: 4893748
• Report Number: 1226348-2014-00428
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2011

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: 05/01/2012
• Device Catalogue Number: BRC00041000
• Device Lot Number: F61157
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2011
• Initial Date FDA Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNK INDEFLATOR