• 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: 8FR 40CC 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: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000263
Device Problem Incomplete or Inadequate Connection (4037)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/11/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon (iab) was inserted into the patient and the intra-aortic balloon pump (iabp) alarmed for "purge failure". The iabp was swapped out and a "purge failure" occurred on the new iabp. As a result, the staff changed to a new iab and the problem was resolved. There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint of "purge failure alarm" is not confirmed. No damage or abnormalities were noted with the returned inflation driveline tubing and the iab catheter. The root cause of the complaint is undetermined. A device history record (dhr) review was not performed. There was no confirmed product failure with the returned sample. No further action is required.
 
Event Description
It was reported that the intra-aortic balloon (iab) was inserted into the patient and the intra-aortic balloon pump (iabp) alarmed for "purge failure". The iabp was swapped out and a "purge failure" occurred on the new iabp. As a result, the staff changed to a new iab and the problem was resolved. There was no report of patient complications, serious injury or death.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREDIGUARD IAB: 8FR 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9555040
MDR Text Key183915244
Report Number3010532612-2019-00464
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K981660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 12/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Model NumberIPN000263
Device Catalogue NumberIAB-S840C
Device Lot Number18F18H0056
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2020
Is This a Reprocessed and Reused Single-Use Device? No

-
-