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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ATLAS PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number AT120184
Device Problems Deflation Problem (1149); Failure to Fold (1255); Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
For the reported complaint, the lot number for the device was provided, a manufacturing review will be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The device was labeled for single use.
 
Event Description
This report summarizes one malfunction. A review of the reported information indicated that model at120184. Pta balloon dilatation catheter allegedly experienced deflation issue, failure to fold, and retraction problem. This report was received from a single source. This event did involve patient with no reported patient injury. The patients age, weight and gender were not provided.
 
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Brand NameATLAS 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)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key9194965
MDR Text Key162448587
Report Number2020394-2019-03970
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
Report Date 10/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAT120184
Device Catalogue NumberAT120184
Device Lot NumberGFCN2167
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 Received09/30/2019
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

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