• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCONQUEST 40 PTA DILATATION CATHETER
Type of DevicePTA 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
Report Number2020394-2019-01804
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 07/24/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/24/2019
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
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

-
-