• 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. BARD ULTRAVERSE 035 PTA DILITATION CATHETER

  • 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. BARD ULTRAVERSE 035 PTA DILITATION CATHETER Back to Search Results
Model Number U3513084
Device Problems Balloon (419); Material Rupture (1546); Component Missing (2306); Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923); Tip (3123)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Device Embedded In Tissue or Plaque (3165)
Event Date 03/03/2017
Event Type  Malfunction  
Event Description

Procedure was endoscopic repair of type ia endoleak ia endovascular aortic aneurysm repair proximal aortic cuff and bilateral renal snorkeling, left iliac limb stenting, uv ultrasound, and left brachial artery exposure and repair. At the conclusion of the procedure the surgeon attempted to dilate the left renal artery using the balloon device, but when attempting to deflate, the balloon ruptured causing the tip to disintegrate when it was pulled back into the sheath. Once removed it was noted that the tip and distal marker were missing. Following examination the distal marker was located and removed. The balloon tip could not be accounted for and is not radiopaque, so could not be located despite attempts to do so. One of the items listed is the defective product. Because two of these items were on the sterile field, it was not possible to determine which item was defective since we could not find any lot number identifier on either product once out of the packaging. Second product information: same product identifiers: lot #5013994, exp date 05/30/2017.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBARD
Type of DeviceULTRAVERSE 035 PTA DILITATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 west 3rd st.
tempe AZ 85281
MDR Report Key6427374
MDR Text Key70815926
Report NumberMW5068595
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/07/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received03/21/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2019
Device MODEL NumberU3513084
Device LOT NumberCMBN0066
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/21/2017 Patient Sequence Number: 1
-
-