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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number U81502H30
Medical Device Problem Codes Inflation Problem (1310); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation confirmed detachment but remains inconclusive for inflation problem.Based upon the available information, 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 information indicated that model u81502h30 pta balloon dilatation catheter allegedly experienced inflation problem and detachment.This information was received from one source.The malfunction did not involve a patient.The patient¿s age, weight, and gender were not provided.
 
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Brand Name
ULTRAVERSE 018 PTA 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 Key9979798
Report Number2020394-2020-03085
Device Sequence Number2168264
Product Code LIT
UDI-Device Identifier00801741064838
UDI-Public(01)00801741064838
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) 04/20/2020
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 NumberU81502H30
Device Catalogue NumberU81502H30
Device Lot NumberCMDU0626
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/31/2020
Initial Report FDA Received Date04/20/2020
Patient Sequence Number1
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