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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE RX PTA BALLOON DILATATION CATHETER

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE RX PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number U4150515RX
Device Problems Break; Kinked; Material Rupture
Event Date 10/06/2017
Event Type  Malfunction  
Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer. The lot number for the device was provided. The device history records are currently under review. The device was returned to the manufacturer for evaluation. The investigation is currently under way. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

 
Event Description

It was reported that during an angioplasty procedure in the sfa, the pta balloon allegedly ruptured at 4atm. The pta balloon was exchanged over the guidewire for another that was used to complete the procedure. There was no reported patient injury.

 
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Brand NameULTRAVERSE RX PTA BALLOON 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
EI 
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe , AZ 85281
4803032689
MDR Report Key7084860
Report Number2020394-2017-01690
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/10/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/05/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/05/2018
Device MODEL NumberU4150515RX
Device Catalogue NumberU4150515RX
Device LOT Number50120892
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/24/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/03/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/05/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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