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 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 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 11/02/2023
Event Type  malfunction  
Event Description
The report states "after insertion, the balloon ruptured and blood entered the balloon".As a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).The reported complaint for "blood entered the balloon" was confirmed based on visual inspection of the returned sample.The customer returned a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging for investigation.The sample was returned in a cardboard box and was in a clear ziplock bag (inp-1, inp-2).Upon return, the iabc bladder was noted withdrawn through the teflon sheath; the sheath was noted on the iabc bladder membrane and covering the iabc distal tip (inp-6).The proximal end of the sheath was noted at approximately 72.6cm from the iabc luer (inp-4).Buckling to the teflon sheath extrusion was noted approximately from 12.5cm to 15.1cm from the distal end of the teflon sheath (inp-7).The one-way valve was tethered to the short driveline tubing (inp-5).The exposed portion of the bladder was fully unwrapped (inp-6).The iabc central lumen was noted broken at approximately 65.2cm from the iabc luer end (inp-8).Various bends were noted to the iabc between 27.0cm to 48.5cm from the iabc luer end (inp-9).A bend was also noted near the iabc bifurcate (inp-10).A dried yellow media was noted on the exterior surfaces of the returned sample.Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was also noted within the iabc helium pathway.Since the iabc bladder was noted withdrawn through the sheath, an in-service has been requested to review the instructions for use (ifu) with the customer.The instructions for use (ifu) states: "do not remove arrow iab through hemostasis sheath introducer or hemostasis device.Once unwrapped (unfurled), balloon profile will not allow passage through the sheath and attempted removal in this manner may result in arterial tearing, dissection or balloon damage." the bladder thickness was measured at six points with measurements ranging from 0.0059in-0.0065in and was within specification of process document.The one-way valve was tested and passed.A vacuum was pulled on the one-way valve, and it held for at least 1 minute and then 30 seconds five separate times according to quality system document.An attempt to aspirate and flush the catheter using a 60cc lab-inventory syringe was unable to be successfully completed and pushback to the syringe was noted; the central lumen was likely blocked by dried blood.The blockage was unable to be cleared.The one-way valve was connected to the short driveline tubing and a vacuum was pulled on the iabc.While maintaining the vacuum, the sheath was removed from the bladder/iabc without difficu lty (anp-1).Upon removal and visual inspection, damage was noted to the iabc central lumen and bladder (anp-2, anp-3).The iabc central lumen within the flex-tip assembly area was noted damaged; the polyimide (part of the flex tip assembly) was noted no longer attached and separated from the inner cannula (iabc central lumen) at approximately 6.5cm from the iabc distal tip (anp-2).The iabc bladder was noted with a leak site at approximately 16.1cm to 17.7cm from the iabc distal tip; the leak site is consistent with being ripped/torn and the damage likely resulted from the broken central lumen.During review of the damages and overall iabc, it was noted that a section of the iabc central lumen was not returned with the sample.The missing section of the central lumen was from 65.2cm from the iabc luer end to the damaged/separated flex tip assembly.The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was immediately detected from the iabc distal tip and bladder.The leak from the iabc distal tip is consistent with the previously confirmed damaged/separated central lumen.The leak from the iabc bladder is consistent with being ripped/torn which likely resulted from the damaged/broken central lumen.No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.The guidewire exited the central lumen and entered the bladder at the location of the flex-tip assembly separation.Some blood was noted.The guidewire was front loaded through the iabc luer.Resistance was noted at approximately 9.3cm, 27.9cm, 32.2cm, and 36.4cm from the iabc luer.The guidewire could not advance at approximately 45.2cm from the iabc luer.No blood or debris was noted.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the blood in the helium pathway.The root cause of how the blood entered the helium pathway is undetermined.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.
 
Event Description
The report states "after insertion, the balloon ruptured and blood entered the balloon".As a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key18133609
MDR Text Key328076596
Report Number3010532612-2023-00646
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 11/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Number18F23F0025
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/07/2023
Initial Date FDA Received11/14/2023
Supplement Dates Manufacturer Received12/27/2023
Supplement Dates FDA Received01/02/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age71 YR
Patient SexMale
Patient Weight75 KG
-
-