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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA CATHETER; PTA BALLOON DILATATION CATHETER
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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA CATHETER; PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number U3575610
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 for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for evaluation.Therefore, the investigation of the reported malfunction was inconclusive.Based upon the available information, the definitive root cause for this event 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 the model u3575610 pta balloon dilatation catheter allegedly ruptured.This information was received from one source.The malfunction involved patient with no known impact to the patient.The patient was a female; however, the age and weight was unknown.
 
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Brand Name
ULTRAVERSE 035 PTA CATHETER
Common Device Name
PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key10306188
Report Number2020394-2020-04808
Device Sequence Number19687333
Product Code LIT
UDI-Device Identifier00801741092985
UDI-Public(01)00801741092985
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 NumberU3575610
Device Catalogue NumberU3575610
Device Lot NumberCMDX0381
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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