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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. VACCESS PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number VA8078
Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/08/2021
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: 04/2024).
 
Event Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured. It was further reported that the balloon came off from the catheter and could not be retrieved. Additional surgery was undergone to remove the device. The current status of the patient is unknown.
 
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Brand NameVACCESS 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 75751
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key12264625
MDR Text Key264695632
Report Number2020394-2021-01416
Device Sequence Number1
Product Code LIT
UDI-Device Identifier00801741059933
UDI-Public(01)00801741059933
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111850
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 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVA8078
Device Catalogue NumberVA8078
Device Lot Number93RF0101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2021
Was Device Evaluated by Manufacturer? Yes
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: 08/03/2021 Patient Sequence Number: 1
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