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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 Codes Break (1069); 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 malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation confirmed break.Based upon the available information, a 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 dr8074 pta dilatation catheter allegedly experienced material rupture and break.This information was received from one source.This malfunction involved one patient with no consequences.The (b)(6) year female was (b)(6) 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 Key9597323
Report Number2020394-2020-00520
Device Sequence Number14078484
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) 01/16/2020
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 NumberDR8074
Device Catalogue NumberDR8074
Device Lot Number93SC0049
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/31/2019
Initial Report FDA Received Date01/16/2020
Patient Sequence Number1
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