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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 U41502H25RX
Device Problems Failure to Advance; Material Deformation
Event Type  Malfunction  
Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review was performed. The device has not been returned for evaluation; therefore, the investigation is inconclusive for the failure to advance and material deformation as no objective evidence has been provided to confirm any alleged deficiency with the device. Based upon the available information, the definitive root cause is unknown. The device is labeled for single use.

 
Event Description

This report summarizes one malfunction. A review of the reported information indicated that model u41502h25rx pta balloon dilatation catheter allegedly experienced material deformation and failure to advance. This information was received from one source. The malfunction involved a patient with no known impact to the patient. The patient was a (b)(6) year old male; weight was 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 Key9591799
Report Number2020394-2020-00298
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 NumberU41502H25RX
Device Catalogue NumberU41502H25RX
Device LOT NumberCMCS0522
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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