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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number U41502H30
Device Problem Peeled / Delaminated
Event Type  Malfunction  
Manufacturer Narrative

The lot number for one of the two reported malfunctions was provided and a lot history review was performed. The device for one malfunction was not returned for evaluation, therefore the investigation is inconclusive for the reported failure. For the other malfunction, the device was returned and the investigation identified peeled outer layer. The definitive root cause is unknown. The devices are labeled for single use.

 
Event Description

This report summarizes two malfunctions. A review of the reported information indicated that model u4102h30 pta balloon dilatation catheter allegedly experienced peeled material. This information was received from various sources. Both events involved a patient with no reported patient injury. Patient age, weight, and gender were not provided.

 
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Brand NameULTRAVERSE 014 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 Key9219899
Report Number2020394-2019-04290
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 10/22/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/22/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberU41502H30
Device Catalogue NumberU41502H30
Device LOT NumberCMDT0579, UNKNOWN
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 Received09/30/2019
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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