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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-06830-U
Device Problem Material Twisted/Bent (2981)
Patient Problem Insufficient Information (4580)
Event Date 07/31/2023
Event Type  malfunction  
Event Description
It was reported that "after 30 minutes of use in the hospital, frequent machine alarms may cause catheter kinked.Adjusting the equipment and catheter cannot solve the problem.After replacing the catheter, the problem was resolved".The 2nd iab was inserted in the same insertion site.No patient harm or injury.The patient status is reported as "fine".
 
Manufacturer Narrative
Qn# (b)(4).
 
Manufacturer Narrative
(b)(4).The reported complaint for iab kinked was confirmed upon the investigation of the returned sample.The customer returned a 30cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) with the original packaging that matches the serial number of the returned iabc (inp-2, inp-3) for investigation.The sample was returned in a cardboard box and was loosely packed within the original packaging carton/tray (inp-1, inp-2).Returned with the sample was the supplied 30cc driveline tubing (inp-4).Upon return, the peel away sheath was noted on the returned iabc (inp-4, inp-9).The one-way valve was tethered to the short driveline tubing (inp-4, inp-6).The bladder was fully unwrapped (inp-7).The iabc central lumen was noted broken within the flex-tip assembly area at approximately 5.8cm from the iabc distal tip (inp-8).Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the bladder/helium pathway.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 due to a blocked/clotted central lumen.Immediate push back on the syringe plunger was experienced.The blockage, most likely dried blood, was unable to be cleared.The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was immediately detected from the iabc distal tip ( anp-1).The leak from the iabc distal tip is consistent with the damaged central lumen (inp-8, anp-2, anp-3).The iabc was leak tested again with the iabc distal tip blocked off; 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 break.Some blood was noted on the guidewire.The guidewire was front loaded through the iabc luer.The guidewire met resistance and could not advance at approximately 1.2cm from the iabc luer due to a blocked central lumen.Some blood was noted on the guidewire.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 damaged central lumen.The root cause of the complaint was undetermined.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.
 
Event Description
It was reported that "after 30 minutes of use in the hospital, frequent machine alarms may cause catheter kinked.Adjusting the equipment and catheter cannot solve the problem.After replacing the catheter, the problem was resolved".The 2nd iab was inserted in the same insertion site.No patient harm or injury.The patient status is reported as "fine".
 
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Brand Name
ULTRAFLEX IAB: 7.5FR 30CC
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 Key18075297
MDR Text Key327427544
Report Number3010532612-2023-00619
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902003751
UDI-Public00801902003751
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 10/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIAB-06830-U
Device Lot Number18F23B0006
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/31/2023
Is the Reporter a Health Professional? No
Date Manufacturer Received12/08/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2023
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 Age55 YR
Patient SexFemale
Patient Weight70 KG
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