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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number CQF7574
Medical Device Problem Code Deflation Problem (1149)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
For the reported malfunction, the device was returned to bd for evaluation.The evaluation identified that the device deflated without issue.Based on the available information, the definite root cause is unknown.The device is labeled for single use.
 
Event or Problem Description
This report summarizes one (1) malfunction.A review of the reported information indicated that model cqf7574 pta balloon dilatation catheter allegedly experienced a deflation issue.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The (b)(6) male patient was (b)(6).
 
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Brand Name
CONQUEST 40 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 Key8812358
Report Number2020394-2019-01661
Device Sequence Number16772692
Product Code LIT
UDI-Device Identifier00801741060496
UDI-Public(01)00801741060496
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) 07/22/2019
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 NumberCQF7574
Device Catalogue NumberCQF7574
Device Lot NumberRECX4317
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/30/2019
Initial Report FDA Received Date07/22/2019
Patient Sequence Number1
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