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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 U4150315RX
Device Problems Failure to Advance (2524); Device-Device Incompatibility (2919); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The lot number for the device was provided and a lot history review was performed.The investigation is inconclusive for the reported guidewire issue, catheter kink and advancement issue, as the device was not returned for evaluation.The definitive root cause for the reported guidewire issue, catheter kink and advancement issue could not be determined based upon available information.The device is labeled for single use.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model u4150315rx pta balloon dilatation catheter allegedly experienced failure to advance, device-device incompatibility, and material deformation.This information was received from one source.One patient was involved and there was no reported patient injury.The male patient is (b)(6) years old and weighs (b)(6) kgs.
 
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Brand Name
ULTRAVERSE RX PTA DILATATION CATHETER
Type of Device
PTA 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 Key9216277
MDR Text Key163124967
Report Number2020394-2019-04215
Device Sequence Number1
Product Code LIT
UDI-Device Identifier00801741056956
UDI-Public(01)00801741056956
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 10/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberU4150315RX
Device Catalogue NumberU4150315RX
Device Lot NumberCMDQ0320
Initial Date Manufacturer Received 09/30/2019
Initial Date FDA Received10/21/2019
Type of Device Usage Initial
Patient Sequence Number1
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