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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. UNK CONQUEST PTA BALLOON DILATATION CATHETER DQY Back to Search Results
Catalog Number UNK CONQUEST
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
A further clinical review was performed and identified this event to be mdr reportable pursuant to 21 cfr part 803. A lot history review could not be performed as the lot number is unk. The investigation is inconclusive as the sample was not returned. The definitive root cause could not be determined based upon the available info. It is unk if patient and/or procedural issues contributed to the reported event. The info provided by bard represents all of the known info at this time. Despite good faith efforts to obtain additional info, the complaint/ reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that the pta balloon size differed from the what was indicating on the labeling. There was no patient injury reported.
 
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Brand NameUNK CONQUEST PTA BALLOON DILATATION CATHETER
Type of DeviceDQY
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
tempe AZ
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V.
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX
Manufacturer Contact
bryan vogel
1625 west 3rd st.
tempe, AZ 85281
4808949515
MDR Report Key4781735
MDR Text Key13334629
Report Number2020394-2015-00398
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 Unknown
Type of Report Initial
Report Date 08/29/2013
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK CONQUEST
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/24/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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