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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 U41501Q1HRX
Device Problems Material Rupture (1546); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The lot number was provided for the malfunction and a lot history review was performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. A definitive root cause could not be determined. The device is labeled for single use.

 
Event Description

This report summarizes one malfunction. A review of the reported information indicated that model u41501q1hrx pta balloon dilatation catheter allegedly experienced failure to advance and balloon rupture. This information was received from one source. This malfunction involved one patient with no consequences. The female patient's age and weight is unknown.

 
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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 Key10310252
MDR Text Key199977901
Report Number2020394-2020-04950
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 07/22/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/22/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberU41501Q1HRX
Device Catalogue NumberU41501Q1HRX
Device LOT NumberCMDV0277
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 Received06/30/2020
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 Initial

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