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 03/22/2011

Event Type  malfunction  

Event Description

The complaint received states that during use the ascent balloon catheter 4 mm x 7 cm (brs00040700 / unk) balloon ruptured during prep.7mm p-com aneurysm ruptured sah-case.Not in lab at time of prep today and balloon popped during prep, before entering patient on back table.When i showed up they explained balloon popped during prep.I was able to provide a balloon at time of arrival and prep went well with me talking them through steps.The physician stated he thought he did all steps correctly.The case went well and no issue with case; 19 coils used and patient is doing well at post procedure.

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 7 cm (brs00040700 / unk) balloon ruptured during prep.7mm p-com aneurysm ruptured sah-case.Not in lab at time of prep today and balloon popped during prep, before entering patient on back table.When i showed up they explained balloon popped during prep.I was able to provide a balloon at time of arrival and prep went well with me talking them through steps.The physician stated he thought he did all steps correctly.The case went well and no issue with case; 19 coils used and patient is doing well at post procedure.The balloon was inspected.No defects were found during the outer surface inspection except on the balloon where a longitudinal tear of 12 mm from the proximal seal to the distal seal was found.The catheter flushed appropriately.Balloon was ruptured so could not be tested.The length between the proximal seal and distal seal was 12.0mm which means 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 prior to release to determine whether the vent hole is open and whether or not the balloon leaks, so it is unlikely that the balloon left micrus with a leak or rupture.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 and handling issues may have contributed to the confirmed event.

• 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: 4087456
• MDR Text Key: 17629641
• Report Number: 1226348-2014-00630
• 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: Other
• Type of Report: Initial
• Report Date: 03/22/2011

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2011
• Initial Date FDA Received: 09/13/2014
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNK INDEFLATOR