MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

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.

• 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 Key: 17557073
• MDR Text Key: 321274568
• Report Number: 3010532612-2023-00463
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• 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 Number: IAB-06840-U
• Device Lot Number: 18F23E0036
• 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 Received: 08/16/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 70 KG