• 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 INC. REDIGUARD IAB: 7FR 30CC SYSTEM, BALLOON, INTRA-AORTIC

  • 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 INC. REDIGUARD IAB: 7FR 30CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000262
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/29/2021
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It was reported that helium loss alarms occurred. This began after the patient experienced severe abdominal pain and retching. The staff did not turn the intra-aortic balloon pump (iabp) back on after the alarms. There is no blood present and no kinks noted. Previous to the alarms the iabp had been supporting the patient without issue. The clinical support specialist (css) instructed the staff to turn the iabp back on and it immediately alarmed possible helium loss 3. The staff decreased intra-aortic balloon (iab) volume to 25cc, immediately alarmed after pumping resumed. The staff decreased to 20cc and again the iabp immediately alarmed after pumping resumed. As a result, the iab was removed. The patient is currently stable, md chose not to reinsert another iab. There was no report of patient complications, serious injury or death. The registered nurse reported that when the iab was removed there were "multiple kinks noted. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREDIGUARD IAB: 7FR 30CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
kaylia pen
16 elizabeth drive
chelmsford, MA 01824
MDR Report Key12063367
MDR Text Key263151387
Report Number3010532612-2021-00161
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K981660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2022
Device Model NumberIPN000262
Device Catalogue NumberIAB-S730C
Device Lot Number18F20C0026
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 Received07/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-