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

Catalog Number BRS00060900

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2011

Event Type  malfunction  

Event Description

The complaint received states that during use two balloons burst during prep, ascent balloon catheter 6 mm x 9 cm (brs00060900 / unk & brs000407-00 / unk).Balloons to be used in balloon test occlusion test.Before using prepped on back table both balloons popped while trying to prep.Exam was cancelled and was rescheduled.Account called me and i went in next day to in-service on prep again.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.This is report 1 of 2 for (b)(4).The complaint received states that during use two balloons burst during prep, ascent balloon catheter 6 mm x 9 cm (brs00060900 / unk & brs000407-00 / unk).Balloons to be used in balloon test occlusion test.Before using prepped on back table both balloons popped while trying to prep.Exam was cancelled and was rescheduled.Account called me and i went in next day to in-service on prep again.There is no report of injury for the patient.Fal: observations: balloon catheter 6x9 f60880: no defects were found during the catheter outer surface inspection except on the balloon area where a longitudinal teat from the proximal seal to the distal seal was found.The length of the tear is 12mm approximately.Balloon catheter 4x7 f38920: no defects were found during the catheter outer surface inspection except on the balloon area where a longitudinal tear from the proximal seal to the distal seal was found.The length of the tear is 16mm approximately.In both cases, the longitudinal tear was found from the proximal deal to the distal seal.This is an indication that the balloons were over inflated which resulted in stretching the balloon and possibly led to 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 reported events and confirmed damage to the devices.

Manufacturer Narrative

Lot number: f60880.

• 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: 4093727
• MDR Text Key: 19089417
• Report Number: 1226348-2014-00685
• 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,Followup
• Report Date: 06/24/2011

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: BRS00060900
• Device Lot Number: F60880
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/24/2011
• Initial Date FDA Received: 09/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK INDEFLATOR