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U.S. Department of Health and Human Services

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

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MICRUS ENDOVASCULAR, LLC ASCENT - BALLOON CATHETER; CES BALLOON CATHETER Back to Search Results
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.
 
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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 Key4093727
MDR Text Key19089417
Report Number1226348-2014-00685
Device Sequence Number1
Product Code MJN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080861
Number of Events Reported1
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 NumberBRS00060900
Device Lot NumberF60880
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/24/2011
Initial Date FDA Received09/16/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/18/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK INDEFLATOR
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