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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ATLA PTA DILATAION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number UNKNOWN ATLAS
Device Problems Difficult to Remove (1528); Retraction Problem (1536); Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The one device belonging to the sole complaint is expected to be returned to bd for evaluation. The company is still investigating the issue at this time.
 
Event Description
This report summarizes 1 malfunction event. A review of the event indicated that model unknown atlas dilatation catheter experienced unraveled material, a retraction problem, and difficulty to remove. This event was reported from a single source. This event involved a patient that had no reported injury. The patient¿s age, weight, and sex were unobtainable.
 
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Brand NameATLA PTA DILATAION 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
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key8515956
MDR Text Key141991141
Report Number2020394-2019-00315
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
Report Date 07/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN ATLAS
Device Lot NumberUNKNOWN
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 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

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