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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA BALLOON DILATATION CATHETERS

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA BALLOON DILATATION CATHETERS Back to Search Results
Model Number U4150430
Device Problems Peeled/Delaminated (1454); Material Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

The lot number was provided for the malfunction and a lot history review was performed. The device was returned for evaluation and the investigation confirmed peeled/delamination. A root cause could not be determined. The device is labeled for single use.

 
Event Description

This report summarizes one malfunction. The information reviewed indicated that model u4150430 pta balloon dilatation catheter allegedly experienced material deformation and peeled/delaminated. The information was received from one source. The malfunction did not involve a patient. The patient was a (b)(6) female weighing 125lbs.

 
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Brand NameULTRAVERSE 014 PTA BALLOON DILATATION CATHETERS
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 Key9975252
MDR Text Key188887452
Report Number2020394-2020-03011
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 04/17/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/17/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberU4150430
Device Catalogue NumberU4150430
Device LOT NumberCMDQ0128
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 Received03/31/2020
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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