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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DORADO PTA DILATATION CATHETER
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BARD PERIPHERAL VASCULAR, INC. DORADO PTA DILATATION CATHETER Back to Search Results
Model Number DR8064
Medical Device Problem Codes Peeled/Delaminated (1454); Material Rupture (1546)
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.Balloon rupture, and peeling pebax 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 dr8064.Pta balloon dilatation catheter allegedly experienced material rupture and peeled.This report was received from a single source.This event did involve patient with no reported patient injury.Age, weight, and gender were not provided for the patient.
 
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Brand Name
DORADO PTA DILATATION CATHETER
Common Device Name
DORADO PTA DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key9597314
Report Number2020394-2020-00517
Device Sequence Number19457802
Product Code LIT
UDI-Device Identifier00801741058721
UDI-Public(01)00801741058721
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 NumberDR8064
Device Catalogue NumberDR8064
Device Lot Number93ND0098
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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