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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 U4150215RX
Device Problems Difficult to Insert; Material Deformation
Event Type  Malfunction  
Manufacturer Narrative

A lot history review was performed. This is the only complaint to date for this lot number. Therefore, a device history record (dhr) review is not required. The sample was returned and a visual inspection was performed. A kink was noted approximately 32. 5 cm from the distal tip. A kink was also noted at the proximal end of the balloon. No anomalies to the luers or bifurcate. The device was evaluated. Guidewire lumen and an in-house 4fr sheath was flushed, then inserted the guidewire. Balloon was aspirated prior to inserting into the sheath. Device was inserted into the sheath without issue, once inside of the sheath balloon was inflated/deflated without issue. Balloon retracted with out any issues. It is unknown whether patient and/or procedural factors contributed to the event. Based on 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 u4150215rx pta balloon dilatation catheter allegedly kinked at the proximal end of the shaft and was difficult to insert into the sheath. Another balloon was used to complete the procedure. There was no reported patient contact. This information was received from one source. The patient was an (b)(6) year-old female who weighed (b)(6) kilograms.

 
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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
EI 
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe , AZ 85281
4803032689
MDR Report Key8817517
Report Number2020394-2019-01760
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 07/23/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/23/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberU4150215RX
Device Catalogue NumberU4150215RX
Device LOT NumberCMDQ0371
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 Received06/30/2019
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 Initial

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