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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018 PTA BALLOON DILATATION CATHETER

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018 PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number U875510
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 03/03/2014
Event Type  malfunction  
Manufacturer Narrative
A further clinical review was performed and identified this event to be mdr reportable pursuant to 21 cfr part 803. The lot number has been provided and the lot device history records have been reviewed. The lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only complaint reported for this lot number and issue to date. The device was not returned. Two photos were provided and reviewed. Based upon the photos provided, the complaint investigation is confirmed for a device markings issue as an ultraverse 018 label was placed on an ultraverse 014 box. The root cause for this event was determined to be manufacturing related. The ultraverse 018 instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that the inner labeling correctly identified the product size as 018; however, the outer box label incorrectly identified the product size as 014. The device was not used on a patient.
 
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Brand NameULTRAVERSE 018 PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
tempe AZ
Manufacturer (Section G)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford
EI
Manufacturer Contact
brett curtice
1625 west 3rd st.
tempe, AZ 85281
4808949515
MDR Report Key4781443
MDR Text Key13291631
Report Number2020394-2015-00356
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K121856
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/03/2014
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2015
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2016
Device Catalogue NumberU875510
Device Lot Number50055752
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location No Information
Date Manufacturer Received03/24/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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