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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 U4150415RX
Device Problems Failure to Advance; Device-Device Incompatibility; Material Deformation
Event Type  Malfunction  
Manufacturer Narrative

The lot number for the malfunction was not provided; therefore, a lot history will not be performed. The device was returned, and was confirmed for material deformation and device-device incompatibility; however, inconclusive for failure to advance. Based upon the available information, the definitive root cause for this event is unknown. The device was labeled for single use.

 
Event Description

This report summarizes one malfunction. A review of the reported information indicated that model u4150415rx pta balloon dilatation catheter allegedly experienced failure to advance and material deformation. This information was received from one source. The event involved a patient with no known impact to the patient. The patient 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 Key9592010
Report Number2020394-2020-00309
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 01/15/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/15/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberU4150415RX
Device Catalogue NumberU4150415RX
Device LOT NumberUNKNOWN
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 Received12/31/2019
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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