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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number CQ7588
Medical Device Problem Codes Material Rupture (1546); Material Deformation (2976)
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 was returned, material rupture and deformation were confirmed.Based upon the available information, a definitive root cause is unknown.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 cq7588 pta balloon dilatation catheter allegedly experienced material rupture and deformation.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient age, weight, and gender were not provided.
 
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Brand Name
CONQUEST 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 Key9596787
Report Number2020394-2020-00471
Device Sequence Number11663583
Product Code DQY
UDI-Device Identifier00801741063138
UDI-Public(01)00801741063138
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 NumberCQ7588
Device Catalogue NumberCQ7588
Device Lot NumberREDT3152
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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