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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE RX PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number U4200210RX
Device Problems Inflation Problem (1310); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2021
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being 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: 03/2022). Device not returned.
 
Event Description
It was reported that during an angioplasty procedure, the pta balloon was allegedly difficult to advance and the balloon was difficult to remove. It was further reported that the balloon detached form the catheter. There was no reported patient injury.
 
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Brand NameULTRAVERSE RX 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)
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 Key12073502
MDR Text Key258610074
Report Number2020394-2021-01251
Device Sequence Number1
Product Code LIT
UDI-Device Identifier00801741056246
UDI-Public(01)00801741056246
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131199
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 07/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU4200210RX
Device Catalogue NumberU4200210RX
Device Lot NumberCMDR0638
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 Received07/20/2021
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

Patient Treatment Data
Date Received: 06/28/2021 Patient Sequence Number: 1
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