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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 VA80104
Device Problems Deflation Problem (1149); Retraction Problem (1536)
Patient Problems Rupture (2208); Blood Loss (2597)
Event Date 04/20/2020
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 not been returned to the manufacturer for evaluation, however photos have been provided. The investigation of the reported event is currently underway. (expiry date: 02/2023).
 
Event Description
It was reported that during an angioplasty procedure, the pta balloon allegedly was unable to go back through the sheath. It was further reported that the balloon tore the vessel at the access site upon removal. Reportedly, the health care provider applied manual pressure for 10 minutes and stitched the vein to control the bleeding. The patient was stable post procedure.
 
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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 TX 75751
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key10030812
MDR Text Key190111578
Report Number2020394-2020-03371
Device Sequence Number1
Product Code LIT
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 06/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVA80104
Device Catalogue NumberVA80104
Device Lot Number93NE0032
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/03/2020
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: 05/06/2020 Patient Sequence Number: 1
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