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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE RX PTA DILATATION CATHETER
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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE RX PTA DILATATION CATHETER Back to Search Results
Model Number U41502H4RX
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.The investigation is inconclusive for the balloon rupture.A definitive root cause for the reported event could not be determined.The device is labeled for single use.
 
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model u41502h4rx pta dilatation catheter allegedly experienced material rupture.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The age and weight of male patient were not provided.
 
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Brand Name
ULTRAVERSE RX PTA DILATATION CATHETER
Common Device Name
PTA DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key10744034
Report Number2020394-2020-06155
Device Sequence Number11627163
Product Code LIT
UDI-Device Identifier00801741056475
UDI-Public(01)00801741056475
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) 10/27/2020
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 NumberU41502H4RX
Device Catalogue NumberU41502H4RX
Device Lot NumberCMDN0078
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/30/2020
Initial Report FDA Received Date10/27/2020
Patient Sequence Number1
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