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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 CATHETER
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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number U4100210
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
The lot number was not provided; therefore, a lot history review was not performed.The sample was not returned to the manufacturer for evaluation.The investigation is inconclusive for the reported balloon rupture.The definitive root cause is unknown.The device is labeled for single use.
 
Event or Problem Description
This report summarizes one malfunction.A review of the reported malfunction indicated that model u4100210 pta balloon dilatation catheter allegedly ruptured.This report was received from one source.One patient was involved with no reported patient injury.Age, weight and gender was not provided.
 
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Brand Name
ULTRAVERSE 014 PTA BALLOON DILATATION CATHETER
Common Device Name
PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key10305417
Report Number2020394-2020-04783
Device Sequence Number515661
Product Code LIT
UDI-Device Identifier00801741053368
UDI-Public(01)00801741053368
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) 07/21/2020
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 NumberU4100210
Device Catalogue NumberU4100210
Device Lot NumberUNKNOWN
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/30/2020
Initial Report FDA Received Date07/21/2020
Patient Sequence Number1
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