• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number U357592
Device Problems Difficult to Insert; Kinked; Retraction Problem
Event Date 06/27/2017
Event Type  Malfunction  
Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer. The lot number for the device was provided. The device history records are currently under review. The device was returned to the manufacturer but will not be evaluated due to potential cross contamination of an infectious disease from another device. The investigation of the reported event is currently underway. 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. Sample not evaluated due to potential cross contamination from another device.

 
Event Description

It was reported that during advancement of the balloon catheter through a 6 fr sheath, strong resistance was met and the catheter allegedly kinked. It was further reported that the health care provider (hcp) attempted to remove the balloon catheter only, but instead removed the catheter, sheath, and guidewire as a single unit, losing access across the lesion. Reportedly, the hcp used another guidewire, sheath, and balloon catheter to complete the procedure. There was no reported patient injury.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameULTRAVERSE 035 PTA BALLOON DILATATION CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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 Key6737054
Report Number2020394-2017-00843
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/07/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/24/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2019
Device MODEL NumberU357592
Device Catalogue NumberU357592
Device LOT NumberCMAX0045
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 Received09/01/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/05/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-