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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 U4150225RX
Device Problems Failure to Advance (2524); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/23/2021
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed. The return of the sample is pending. The investigation of the reported event is currently underway. (expiration date: 01/2024).
 
Event Description
It was reported that during an angioplasty procedure of a calcified target lesion below the knee, the pta balloon was allegedly unable to cross the lesion and the catheter shaft was kinked. The procedure was completed by using another device. 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 Key13314887
MDR Text Key284182997
Report Number2020394-2021-02188
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,Followup
Report Date 01/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU4150225RX
Device Catalogue NumberU4150225RX
Device Lot NumberCMFP0281
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/24/2022
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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