Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 ARROW ULTRAFLEX IAB: 7.5FR 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 LLC ARROW ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN917530
Device Problems Fluid/Blood Leak (1250); Patient Device Interaction Problem (4001)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/07/2024
Event Type  malfunction  
Event Description
It was reported "upon sitting the patient up, blood was noticed in the helium line and the balloon alarmed.Helium line was clamped and removed from pump.Patient haemodynamically stable." the patient's current condition is reported as "deceased".It was reported "cause of death was hypoxic injury linked to out of hospital cardiac arrest.".
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported "upon sitting the patient up, blood was noticed in the helium line and the balloon alarmed.Helium line was clamped and removed from pump.Patient haemodynamically stable." the patient's current condition is reported as "deceased".It was reported "cause of death was hypoxic injury linked to out of hospital cardiac arrest.".
 
Manufacturer Narrative
(b)(4).The reported complaint that "blood was noticed in the helium line and the balloon alarmed" is not able to be confirmed.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARROW ULTRAFLEX IAB: 7.5FR 40CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
marling heaton
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key18948926
MDR Text Key338230937
Report Number3010532612-2024-00172
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902026804
UDI-Public00801902026804
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K000729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2024
Device Model NumberIPN917530
Device Catalogue NumberIAB-06840-U
Device Lot Number18F22C0020
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/16/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/11/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NONE REPORTED; NONE REPORTED
-
-