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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-06840-U
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/20/2023
Event Type  malfunction  
Event Description
It was reported that after a successful insertion of the iab, the next day, "a small amount of blood stains were found at the head end of the aortic balloon helium tubing, and the machine was operating normally with no alarms.By 10:30 the machine had a pressure alarm and more blood stains in the helium tube, consider the possibility of balloon rupture.The iabp device was removed".A 2nd iab was not inserted.No patient harm or injury.The patient status is reported as "fine".
 
Manufacturer Narrative
(b)(4) other remarks: n/a corrected data: n/a.
 
Manufacturer Narrative
(b)(4).The reported complaint for "blood stains in the helium tube" was not able to be confirmed as 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.Teleflex will continue to monitor and trend on complaints of this nature.
 
Event Description
It was reported that after a successful insertion of the iab, the next day, "a small amount of blood stains were found at the head end of the aortic balloon helium tubing, and the machine was operating normally with no alarms.By 10:30 the machine had a pressure alarm and more blood stains in the helium tube, consider the possibility of balloon rupture.The iabp device was removed".A 2nd iab was not inserted.No patient harm or injury.The patient status is reported as "fine".
 
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Brand Name
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
kevin don bosco
3015 carrington mill blvd
morrisville 27560
MDR Report Key18050480
MDR Text Key327100944
Report Number3010532612-2023-00599
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902026804
UDI-Public00801902026804
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K000729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIAB-06840-U
Device Lot Number18R23G0002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/30/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/04/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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