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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIAN EVERCROSS 0.035 6X200 PTA BALLOON CATHETER BALLOON CATHETER, AB35W06200135

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COVIDIAN EVERCROSS 0.035 6X200 PTA BALLOON CATHETER BALLOON CATHETER, AB35W06200135 Back to Search Results
Lot Number A077972
Device Problems Balloon rupture; Balloon burst
Event Date 04/16/2015
Event Type  Injury  
Event Description

During a femoral angioplasty and stent placement to the pt's right femoral artery, the balloon ruptured and came off of the shaft. The physician used a snare to capture the balloon. Another balloon catheter was used. A small perforation to the right femoral artery was noted and a viabahn stent was used to cover the area. Good blood flow noted in vessel after stent placed.

 
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Brand NameEVERCROSS 0.035 6X200 PTA BALLOON CATHETER
Type of DeviceBALLOON CATHETER, AB35W06200135
Manufacturer (Section D)
COVIDIAN
3033 campus drive
plymouth MN 55441
MDR Report Key4812537
Report Number4812537
Device Sequence Number1
Product CodeLIT
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/22/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/01/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/22/2018
Device LOT NumberA077972
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/20/2015
Event Location Other
Date Report TO Manufacturer04/23/2015
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 06/01/2015 Patient Sequence Number: 1
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