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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 CQF7584
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The devices were not returned for evaluation.However, 6 photos were provided for one of the devices.A lot history review was performed.The investigation confirmed the device markings issue for on device.This issue is inconclusive for the remaining 5 devices.The investigation was not able to determine a root cause.The device was labeled for single use.
 
Event Description
This report summarizes 6 malfunctions.A review of the events indicated that model cqf7584 experienced a device markings issue.These reports were received from various sources.The six devices were not used in the patient.
 
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Brand Name
CONQUEST 40 PTA DILATATION CATHETER
Type of Device
PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V.
blvd montebello #1
parque industrial colonial
reynosa tamaulipas 88780
MX   88780
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key8822917
MDR Text Key152087140
Report Number2020394-2019-01804
Device Sequence Number1
Product Code LIT
UDI-Device Identifier00801741060557
UDI-Public(01)00801741060557
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 07/24/2019
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
Device Operator No Information
Device Model NumberCQF7584
Device Catalogue NumberCQF7584
Device Lot NumberREDQ3444
Initial Date Manufacturer Received 06/30/2019
Initial Date FDA Received07/24/2019
Type of Device Usage Initial
Patient Sequence Number1
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