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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 U4150530RX
Device Problems Kinked; Detachment of Device or device Component
Event Date 07/04/2016
Event Type  Malfunction  
Manufacturer Narrative

As a result of a retrospective review of events that occurred in japan and in accordance with 21 c. F. R. Part 803, this event was assessed and determined to be mdr reportable. Manufacturing review: the device history records have been reviewed and this lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. Investigation summary: the device was not returned, however two electronic photos were provided for review. Based on the photo review, the investigation is confirmed for both the reported kink, as well as for a complete detachment of the catheter shaft. The definitive root cause for the reported kink or identified detached catheter could not be determined based upon available information. It is unknown whether procedural issues contributed to the event. Labeling review: the current (b)(6) ifu (instructions for use) states: warnings: - to prevent vessel damage, the inflated diameter and length of the balloon should approximate the diameter and length of the vessel just proximal and distal to the stenosis. Select a balloon size so that its inflated balloon diameter does not exceed the minimum vessel diameter when diameters of a target vessel vary. [or, it can cause vessel injury. ] - when the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated. If resistance is met during manipulation, determine the cause of the resistance before proceeding. [applying excessive force to the catheter can cause vessel damage and the catheter can result in tip or catheter breakage, catheter kink or balloon separation. ] - do not exceed the rbp recommended for this device. To prevent over pressurization, use of inflation device with manometer is recommended. [balloon rupture may occur if the rbp rating is exceeded. ] - careful attention must be paid to the dilatation of calcified lesions or tortuous anatomy. [it may lead to catheter damage or balloon rupture. Prohibitions: - do not reuse. - do not resterilize. 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 a treatment for a lesion, the shaft of the pta balloon catheter allegedly kinked. 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 Key7038518
Report Number2020394-2017-01573
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/05/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/16/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2018
Device MODEL NumberU4150530RX
Device Catalogue NumberU4150530RX
Device LOT Number50130038
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/16/2015
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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