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

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS INC. ATLAS GOLD / DILATION CATHETER ANGIOPLASTY BALLOON / DILATION 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 ACCESS SYSTEMS INC. ATLAS GOLD / DILATION CATHETER ANGIOPLASTY BALLOON / DILATION CATHETER Back to Search Results
Catalog Number AT680164
Device Problems Shaft (955); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/29/2015
Event Type  Injury  
Event Description

(b)(4), event date: (b)(6) 2015. While performing a venous angioplasty in the subclavian vein, the angioplasty balloon dislodged from the shaft and became free floating in the superior vena cava. It passed through the right side of the heart and lodged in the right pulmonary artery. Radiologist came to assist and proceeded to successfully snare the balloon from the right pulmonary artery via the right femoral vein approach. Pt tolerated well and was sent to icu for observation. Primary surgeon notified bard sales rep and notified of event. He then in turn notified his immediate supervisor of bard who reported event within bard.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameATLAS GOLD / DILATION CATHETER
Type of DeviceANGIOPLASTY BALLOON / DILATION CATHETER
Manufacturer (Section D)
BARD ACCESS SYSTEMS INC.
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key5347431
MDR Text Key35242210
Report NumberMW5058910
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation NURSE
Type of Report Initial
Report Date 12/31/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/31/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/01/2018
Device Catalogue NumberAT680164
Device LOT Number93120180
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? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/31/2015 Patient Sequence Number: 1
-
-