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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 Material Twisted/Bent (2981)
Patient Problem Needle Stick/Puncture (2462)
Event Date 07/17/2023
Event Type  Injury  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
The initial report states, "during surgery, the packaging was opened and the catheter was found kinked, then the doctor changed a new one.It was successful".However preliminary review of the returned sample showed that the device was used on a patient.Additional information received states that "when the doctor opened the package, he found the catheter was kinked.But the patient is very critical.So the doctor continue to use the product to continue the operation.So the blood was found on the catheter." the doctor inserted the catheter knowing there was a kink in it.As a result, the catheter was removed and a 2nd catheter was inserted at a different insertion site.No patient harm or injury.The patient status is reported as "fine".
 
Manufacturer Narrative
(b)(4) the reported complaint of iab kinked was confirmed based upon the sample received.The customer returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in a cardboard box and was in a clear plastic bag (inp-1, inp-2).Upon return, the one-way valve was tethered to the short driveline tubing (inp-5).The bladder was fully unwrapped (inp-6).The sheath with sidearm was noted on the iabc.Blood was noted within the sidearm and buckling to the sheath was noted (inp-4).The iabc central lumen within the flex-tip assembly area was noted damaged; the wire round/polyimide (part of the flex tip assembly) was noted broken at approximately 6.0cm from the iabc distal tip (inp-7).Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was also noted within the iabc helium pathway.No other damage or abnormalities were noted to the returned sample.The one-way valve was tested and failed.A vacuum was pulled on the one-way valve, and it immediately lost pressure.This was repeated five separate times according to quality system document q-96 with similar results.Blood was noted within the one-way valve and on the one-way valve seal upon cleaning (anp-1).The one-way valve was properly cleaned and tested again; the one-way valve 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 iabc central lumen using a 60cc lab-inventory syringe was unable to be successfully completed.Upon aspiration, water was unable to be consistently pulled into the syringe.The attempt to flush resulted in bladder inflation.The results are consistent with the previously noted damaged central lumen (inp-7).The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was immediately detected from the iabc distal tip and luer end (anp-2, anp-3).The leak noted from the iabc distal tip and luer end are consistent with the previously noted damaged iabc central lumen (inp-7).The iabc was leak tested again with the iabc distal tip and iabc luer end 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 central lumen break.No blood or debris was noted.The guidewire was front loaded through the iabc luer.Resistance was noted at approximately 9.5cm from the iabc luer.The guidewire exited the central lumen and entered the bladder at the location of the central lumen break.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 damaged catheter.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 for reports of this nature.Other remarks: n/a corrected data: n/a.
 
Event Description
The initial report states, "during surgery, the packaging was opened and the catheter was found kinked, then the doctor changed a new one.It was successful".However preliminary review of the returned sample showed that the device was used on a patient.Additional information received states that "when the doctor opened the package, he found the catheter was kinked.But the patient is very critical.So the doctor continue to use the product to continue the operation.So the blood was found on the catheter." the doctor inserted the catheter knowing there was a kink in it.As a result, the catheter was removed and a 2nd catheter was inserted at a different insertion site.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 Key17596441
MDR Text Key321657149
Report Number3010532612-2023-00471
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 08/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2023
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 Number18F22F0054
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2023
Is the Reporter a Health Professional? No
Date Manufacturer Received11/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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