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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number U3513054
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/02/2016
Event Type  malfunction  
Event Description
The ultraverse balloon was placed into position and preparation for inflation was attempted.The balloon preparation was unsuccessful due to a leak somewhere in the hub that would not allow the preparation to be completed.The patient was unharmed and the balloon was withdrawn without incident.The procedure was completed with another balloon.Manufacturer response for bard ultraverse pta dilation catheter, pta dilation catheter (per site reporter): they replaced the device.
 
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Brand Name
ULTRAVERSE
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 west 3rd street
tempe AZ 85281
MDR Report Key5543922
MDR Text Key41753097
Report Number5543922
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date09/30/2016
Device Catalogue NumberU3513054
Device Lot Number50115823
Other Device ID Number080174109671
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2016
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/11/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer02/11/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/04/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
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