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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 U4150230RX
Device Problems Failure to Advance (2524); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

As the lot number for the device was provided, a lot history review was performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation is inconclusive for the reported failure to advance and material deformation. Based on the available information, the definitive root cause for this event is unknown. The device is labeled for single use.

 
Event Description

This report summarizes one malfunction. A review of the reported information indicates that model u4150230rx ultraverse rx pta dilatation catheter allegedly experienced failure to advance and material deformation. The information was received from a single source. This malfunction involved one patient with no patient consequences. Patients' age, weight and gender were not provided.

 
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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
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key10744139
MDR Text Key213322178
Report Number2020394-2020-06159
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 10/27/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/27/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberU4150230RX
Device Catalogue NumberU4150230RX
Device LOT NumberCMDY0052
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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