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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018 PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018 PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number U8130415
Device Problem Material Puncture / Hole
Event Type  Malfunction  
Manufacturer Narrative

The device for this malfunction has been returned to the manufacturer for evaluation. The investigation of the reported malfunction is currently underway. The device is labeled for single use.

 
Event Description

This report summarizes one malfunction. A review of the reported information indicated that model u8130415 pta balloon dilatation catheter allegedly experienced material puncture. This information was received from a single source. The malfunction involved a patient with no reported consequence. The patient was reported as a (b)(6)-year-old male whose weight was not provided.

 
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Brand NameULTRAVERSE 018 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 Key8814310
Report Number2020394-2019-01724
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 07/22/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/22/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberU8130415
Device Catalogue NumberU8130415
Device LOT NumberCMCT0503
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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