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

MAUDE Adverse Event Report: ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED) AC3 OPTIMUS IABP TELEFLEX MEDICAL SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

  • 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
 

ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED) AC3 OPTIMUS IABP TELEFLEX MEDICAL SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problems Therapeutic or Diagnostic Output Failure (3023); Physical Resistance/Sticking (4012)
Patient Problems Chest Pain (1776); Failure of Implant (1924)
Event Date 10/05/2021
Event Type  Injury  
Event Description
An (b)(6) year old female with significant dementia that presented to (b)(6) with chest pain and was taken emergently to the cath lab for pci/stenting and had an iabp placed (about 1:15 pm on 10/5). At 21:00 on (b)(6) 2021 the rn noticed blood flecks in the tubing. The balloon pump was stopped at 22:00. At 23:00 at physician attempted to remove the balloon at the beside but it became "stuck". The patient was then taken to the operating room to have it surgically removed. There is a wound vac in place and the distal pulses are good. The patient is recovering. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAC3 OPTIMUS IABP TELEFLEX MEDICAL
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED)
MDR Report Key12624479
MDR Text Key276413063
Report NumberMW5104561
Device Sequence Number1
Product Code DSP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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: 10/12/2021 Patient Sequence Number: 1
-
-