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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. DORADO PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number DR80610
Device Problems Inflation Problem (1310); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review was performed. The sample was not returned to the manufacturer for evaluation. Therefore, the investigation of the reported event is inconclusive for inflation problem, balloon detachment and difficult to remove. Based upon the available information, the definitive root cause for this event is unknown. The device is labeled for single use.
 
Event Description
This report summarizes three malfunction. A review of the reported information indicated that model dr80610 pta dilatation catheter allegedly experienced inflation problems, balloon detachment and was difficult to remove. The malfunction had no patient contact.
 
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Brand NameDORADO 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 Key10286774
MDR Text Key199246875
Report Number2020394-2020-04543
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,Followup
Report Date 07/17/2020
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 NumberDR80610
Device Catalogue NumberDR80610
Device Lot Number93VD0062
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 Received06/30/2020
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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