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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ATLAS GOLD PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number ATG80144
Device Problems Retraction Problem (1536); Material Rupture (1546); Unraveled Material (1664); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The one device belonging to the sole malfunction is expected to be returned to bd for evaluation. The company is still investigating the issue at this time. The device is labeled for single use.
 
Event Description
This report summarizes one malfunction. A review of the reported information indicated that model atg80144 pta balloon dilatation catheter allegedly experienced a material rupture and a detachment of device or device component. This information was received from a single source. The malfunction involved a patient with no reported consequence. The patient was reported as a (b)(6) year old male whose weight was not provided.
 
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Brand NameATLAS GOLD 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)
FUTUREMATRIX INTERVENTIONAL
1605 enterprise street
athens TX 75751
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key9215813
MDR Text Key163132229
Report Number2020394-2019-04178
Device Sequence Number1
Product Code LIT
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,Followup,Followup
Report Date 03/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberATG80144
Device Catalogue NumberATG80144
Device Lot Number93UD0064
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2020
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 Initial

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