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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 07/18/2023
Event Type  malfunction  
Event Description
It was reported that "during the insertion of iabp in the icu, the catheter was placed smoothly, but it could not be used normally.There was an air leak alarm, and after removal, it was found that the head of the balloon was damaged." 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
Qn#(b)(4).N/a other remarks: n/a.Corrected data: n/a.
 
Event Description
It was reported that "during the insertion of iabp in the icu, the catheter was placed smoothly, but it could not be used normally.There was an air leak alarm, and after removal, it was found that the head of the balloon was damaged." 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
Qn#(b)(4).No serial number was reported.The serial number of the returned sample is (b)(6).The lot number (18f23e0014) reported on the complaint report does not match the lot number for the returned sample.The lot number for the returned sample is (b)(6).Additional information obtained from a teleflex representative indicates the returned sample is the correct iabc for this complaint.Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) with the original packaging.Returned with the sample were semi-finished kit components including 40cc inflation driveline tubing and datascope driveline tubing.Blood was noted on the exterior and interior surfaces of the inflation driveline tubing.Also returned with the sample were the red luer end-cap, ap extension tubing, and a non-teleflex syringe with no damage or blood noted.Two retention tubes (from the original packaging tray) were returned on the unwrapped bladder forcefully stretching the end of the bladder toward the proximal end of the iabc.The iabc was returned with the stylet inserted in the central lumen.The one-way valve was connected and tethered to the short driveline tubing.Blood was noted on the exterior surfaces of the iabc and blood was noted in the helium pathway.Additionally, the original packaging tray was noted with damage to the "arrow" packaging sticker which retains the iabc bladder in the packaging tray.The arrow sticker was noted cut and peeled back.This packaging sticker is not to be removed or tampered with in any fashion.The instructions for use (ifu) states: "1.Connect one-way valve to male luer on short driveline tubing attached to iab.Insert supplied syringe into one-way valve.Slowly aspirate a full syringe of air.Precaution: the one-way valve will maintain vacuum on the balloon and must remain in place until is fully inserted.Remove syringe.2.Remove catheter from tray, keeping it in line with balloon membrane.3.Grasp catheter close to tray and pull it t straight out of the holding sleeve.Note: keep catheter level with tray.Do not lift or bend during removal." the bladder thickness was measured at six points with measurements ranging from 0.0055in-0.0056in and was within specification.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 q-96.The one-way valve was connected to the short driveline tubing and a negative vacuum was pulled on the one-way valve.While maintaining the vacuum, the iabc was removed from the retention tubes.No additional damage or abnormality was noted to the bladder.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.No resistance was noted; the guidewire was able to advance through the central lumen.No blood or debris was noted.The guidewire was front loaded through the iabc luer.No resistance was noted; the guidewire was able to advance through the central lumen.No blood or debris was noted.The iabc bladder was slowly, manually inflated using a 60cc lab-inventory syringe due to the returned state of the device and in order to properly leak test the device.The iabc was leak tested and no leaks were detected.Full inflation was achieved.The device passed the leak test.Due to the returned state of the device, further testing was performed in order to determine how blood entered the bladder.The interior of the bladder was rinsed with warm water in order to ensure dried blood was not blocking any potential leak site.The leak test was performed again and passed.The proximal and distal ends of the iabc/bladder were tugged with moderate force to ensure the components were properly attached.The distal tip had separated and was no longer attached to the central lumen.The central lumen and distal tip separation could have allowed blood to enter the bladder.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint of the iab "could not be used normally" is confirmed.During the investigation of the returned sample, the iab catheter distal tip separated and was no longer attached to the central lumen.This could cause blood to enter the helium pathway and result in the device not being able to be used.Additionally, the original packaging tray was noted with damage to the "arrow" packaging sticker which retains the iabc bladder in the packaging tray.This indicates the iabc was not prepped per the instructions for use (ifu) and could result in damage to the device.As a result, an in-service has been requested to review the instructions for use (ifu) with the customer.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 to the distal tip separation.The root cause of the complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.
 
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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
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key17557073
MDR Text Key321274568
Report Number3010532612-2023-00463
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 07/31/2023
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 Number18F23E0036
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/31/2023
Initial Date FDA Received08/16/2023
Supplement Dates Manufacturer Received09/19/2023
Supplement Dates FDA Received09/20/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/18/2023
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 SexFemale
Patient Weight70 KG
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