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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA BALLOON DILATATION CATHETERS

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA BALLOON DILATATION CATHETERS Back to Search Results
Model Number U4150222
Device Problems Break (1069); Packaging Problem (3007)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The lot number was provided for the malfunction a lot history review was performed. The device was returned for evaluation and the investigation confirmed for break and packaging problem. A root cause could not be determined. The device is labeled for single use.
 
Event Description
This report summarizes one malfunction. The information reviewed indicated that model u4150222 pta balloon dilatation catheter allegedly experienced packaging problem and break. This information was received from one source. The malfunction involved (b)(6) patient with no reported consequences. No other patient information was reported.
 
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Brand NameULTRAVERSE 014 PTA BALLOON DILATATION CATHETERS
Type of DevicePTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford N A
EI N A
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key9963897
MDR Text Key189203916
Report Number2020394-2020-02731
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 Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 04/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU4150222
Device Catalogue NumberU4150222
Device Lot NumberCMCS0325
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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