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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA DILATATION CATHETER

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BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA DILATATION CATHETER Back to Search Results
Model Number CQ7564
Device Problems Material Frayed (1262); Peeled/Delaminated (1454); Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2018
Event Type  malfunction  
Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer. As the lot number for the device was provided, a review of the device history records is currently being performed. The return of the device is pending. The investigation of the reported event is currently underway. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that during an angioplasty procedure to declot the avf of the basilic vein, using a bareback approach, the pta dilatation catheter balloon coating allegedly peeled off upon the second attempt to reintroduce the device. It was further reported that there was allegedly difficulty retracting through the sheath. Another device was used to complete the procedure. There was no reported patient injury.
 
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Brand NameCONQUEST PTA DILATATION CATHETER
Type of DevicePTA 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 Key8021788
MDR Text Key125599503
Report Number2020394-2018-01957
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCQ7564
Device Catalogue NumberCQ7564
Device Lot NumberREBX0392
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/18/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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