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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 DR4054
Medical Device Problem Codes Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.Leak and break was confirmed for the device.A root cause has not been determined.The device was labeled for single use.
 
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model dr4054.Pta balloon dilatation catheter allegedly experienced break and leak.This report was received from a single source.This event did involve patient with no reported patient injury.The patients age, weight and gender were not provided.
 
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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 Key9198661
Report Number2020394-2019-04012
Device Sequence Number408980
Product Code DQY
UDI-Device Identifier00801741058486
UDI-Public(01)00801741058486
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 NumberDR4054
Device Catalogue NumberDR4054
Device Lot Number93XC0170
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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