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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 CQF7594
Medical Device Problem Code Burst Container or Vessel (1074)
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 will be performed.The device has been returned for evaluation; the evaluation is confirmed for the reported catheter shaft bursts.Based upon the available information, the 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 cqf7594 pta balloon dilatation catheter allegedly experienced a burst.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The (b)(6) year old female 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 Key9198589
Report Number2020394-2019-04009
Device Sequence Number11550099
Product Code LIT
UDI-Device Identifier00801741060601
UDI-Public(01)00801741060601
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 a Product Problem Report? Yes
Operator of Device No Information
Device Model NumberCQF7594
Device Catalogue NumberCQF7594
Device Lot NumberREDR3734
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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