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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 ATG120144
Device Problems Material Frayed (1262); Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/03/2018
Event Type  malfunction  
Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer. As the lot number for the device was provided, a review of the device history records is currently being performed. The device has been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway.
 
Event Description
It was reported that during an angioplasty procedure in the iliac vein, the pta balloon allegedly had unraveled material. Another device was used to complete the procedure. There was no reported patient injury.
 
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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
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key8177399
MDR Text Key130895311
Report Number2020394-2018-02216
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberATG120144
Device Catalogue NumberATG120144
Device Lot Number93WC0072
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/28/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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