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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA BALLOON DILATATION CATHETER

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BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number CQF7564
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 04/01/2014
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. The device history records have been reviewed with special attention to the raw materials, the subassemblies, the manufacturing process and the quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only complaint reported to date for this failure mode. The sample was returned and two electronic photos were provided for review. The investigation is confirmed for a device markings issue as the hub reflected a different balloon size than was present on the catheter. The root cause for this event was determined to be manufacturing related. Based upon the image review, no conclusions can be drawn regarding the reported event. The ifu (instructions for use) states: precautions: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition was suitable for the procedure for which it is to be used. Do not use if product damage is evident. 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 the balloon size on the hub differed from the labeling. There was no patient involvement.
 
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Brand NameCONQUEST 40 PTA BALLOON DILATATION CATHETER
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 Key4781438
MDR Text Key13446631
Report Number2020394-2015-00185
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/01/2014
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 Expiration Date01/31/2017
Device Catalogue NumberCQF7564
Device Lot NumberREYA0193
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/08/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/24/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2014
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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