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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 U4150430
Medical Device Problem Codes Peeled/Delaminated (1454); Material Deformation (2976)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number was provided for the malfunction and a lot history review was performed.The device was returned for evaluation and the investigation confirmed peeled/delamination.A root cause could not be determined.The device is labeled for single use.
 
Event or Problem Description
This report summarizes one malfunction.The information reviewed indicated that model u4150430 pta balloon dilatation catheter allegedly experienced material deformation and peeled/delaminated.The information was received from one source.The malfunction did not involve a patient.The patient was a (b)(6) female weighing 125lbs.
 
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Brand Name
ULTRAVERSE 014 PTA BALLOON DILATATION CATHETERS
Common Device Name
PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key9975252
Report Number2020394-2020-03011
Device Sequence Number19490123
Product Code LIT
UDI-Device Identifier00801741064548
UDI-Public(01)00801741064548
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model NumberU4150430
Device Catalogue NumberU4150430
Device Lot NumberCMDQ0128
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/31/2020
Initial Report FDA Received Date04/17/2020
Patient Sequence Number1
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