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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 U3513034
Medical Device Problem Codes Device Damaged Prior to Use (2284); 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 sample was not returned; however a photo has been provided and reviewed.The investigation reported issue was confirmed for the detachment.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 u3513034 035 pta catheter allegedly experienced damage prior to use and detachment.This information was received from one source.This malfunction did not involve patient.Age, weight, and gender of the patient was not provided.
 
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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 Key10305099
Report Number2020394-2020-04773
Device Sequence Number16272350
Product Code LIT
UDI-Device Identifier00801741091674
UDI-Public(01)00801741091674
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 NumberU3513034
Device Catalogue NumberU3513034
Device Lot NumberCMCV0174
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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