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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 DILATION CATHETER

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE RX PTA DILATATION CATHETER PTA DILATION CATHETER Back to Search Results
Model Number U415064RX
Device Problems Break (1069); Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/05/2020
Event Type  Malfunction  
Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. (expiry date: 02/2023).

 
Event Description

It was reported that during an angioplasty procedure of highly calcified lesion in the superficial femoral artery via ipisrateral approach, the catheter was unable to cross the lesion. It was further reported that the catheter shaft allegedly broken. There was no reported patient injury.

 
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Brand NameULTRAVERSE RX PTA DILATATION CATHETER
Type of DevicePTA DILATION 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
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key10933017
MDR Text Key219133645
Report Number2020394-2020-20724
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK131199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 11/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/02/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberU415064RX
Device Catalogue NumberU415064RX
Device LOT NumberCMEQ0450
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 Received11/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/02/2020 Patient Sequence Number: 1
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