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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DORADO PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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BARD PERIPHERAL VASCULAR, INC. DORADO PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number DR8074
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number for the devices was provided and a lot history review was performed.The devices were not returned, therefore the investigation is inconclusive for the alleged issue.The definitive root cause could not be established.The device is labeled for single use.
 
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model dr8074 pta balloon dilatation catheter allegedly experienced break.This information was received from one source.One patient was involved and there was no reported patient injury.The male patient is (b)(6) years old and weighs 63 kgs.
 
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Brand Name
DORADO 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 Key9198954
Report Number2020394-2019-04018
Device Sequence Number16219856
Product Code DQY
UDI-Device Identifier00801741058981
UDI-Public(01)00801741058981
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) 10/16/2019
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 NumberDR8074
Device Catalogue NumberDR8074
Device Lot Number93NC0184
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/30/2019
Initial Report FDA Received Date10/16/2019
Patient Sequence Number1
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