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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE RX PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number U415044RX
Device Problems Failure to Advance (2524); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/12/2021
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. (expiry date: 11/2023).
 
Event Description
It was reported that during an angioplasty procedure, the pta balloon was allegedly unable to cross lesion and the shaft of the catheter was allegedly found to be kinked. It was further reported that another device was used to complete the procedure. There was no reported patient injury.
 
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Brand NameULTRAVERSE RX
Type of DevicePTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford N A
EI N A
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key12967830
MDR Text Key282104143
Report Number2020394-2021-02059
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU415044RX
Device Catalogue NumberU415044RX
Device Lot NumberCMEZ0256
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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