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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ULTRAVERSE ULTRAVERSE PTA DILITATION CATHETER

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BARD ULTRAVERSE ULTRAVERSE PTA DILITATION CATHETER Back to Search Results
Catalog Number U35130610
Device Problem Burst Container or Vessel (1074)
Patient Problem No Information (3190)
Event Date 09/07/2017
Event Type  Injury  
Event Description
An ultraverse 6. 0mmx100mm balloon was fed into place and the distal area was treated without any problems. The balloon burst on the second inflation. When it was retrieved the tip and part of the balloon were missing. Under fluoroscopy, dr. (b)(6) identified a piece of the balloon against the vessel wall. A 6x4 self-expanding stent was placed to trap the balloon.
 
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Brand NameULTRAVERSE
Type of DeviceULTRAVERSE PTA DILITATION CATHETER
Manufacturer (Section D)
BARD
tempe AR
MDR Report Key6862535
MDR Text Key86102072
Report Number6862535
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
Type of Report Initial
Report Date 09/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2019
Device Catalogue NumberU35130610
Device Lot NumberCMAX0128
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/08/2017
Distributor Facility Aware Date09/07/2017
Event Location No Information
Date Report to Manufacturer09/07/2017
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/08/2017 Patient Sequence Number: 1
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