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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number CQ75104
Device Problems Break (1069); Inflation Problem (1310); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a lot history review was performed. The sample was returned to the manufacturer for inspection/evaluation. The investigation is confirmed for inflation issue, break and twisted inner catheter. A definitive root cause for the reported event could not be determined. The device is labeled for single use.
 
Event Description
This report summarizes one malfunction. A review of the reported information indicated that model cq75104 pta balloon dilatation catheter allegedly experienced inflation problem, break and material twisted. This information was received from one source. The event involved a patient with no known impact to the patient. The (b)(6) year old female patient was (b)(6) lbs.
 
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Brand NameCONQUEST 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
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key10286849
MDR Text Key199248926
Report Number2020394-2020-04557
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 07/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCQ75104
Device Catalogue NumberCQ75104
Device Lot NumberREDV3158
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 Received06/30/2020
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

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