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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 ATG120184
Device Problem Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)
Event Date 11/30/2018
Event Type  Injury  
Manufacturer Narrative
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. (expiry date: 04/2021). The information provided by bd represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
It was reported that during an angioplasty procedure in the superior vena cava, the pta balloon was allegedly found to be detached. A snare was used to retrieve the detached material, via an alternate access site. No further treatment was needed. 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 Key8337526
MDR Text Key136110818
Report Number2020394-2019-00123
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K181323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberATG120184
Device Catalogue NumberATG120184
Device Lot Number93PC0084
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/13/2019 Patient Sequence Number: 1
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