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

Catalog Number IAB-06840-U

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2023

Event Type  malfunction  

Event Description

It was reported that "after 3 minutes of use, the machine frequently alarms and the catheter may be kinked.Adjusting the equipment and catheter cannot solve the problem.After replacing the catheter, the problem was resolved".The 2nd catheter was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "after 3 minutes of use, the machine frequently alarms and the catheter may be kinked.Adjusting the equipment and catheter cannot solve the problem.After replacing the catheter, the problem was resolved".The 2nd catheter was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).No serial number was reported.The serial number on the returned sample is el21421.The reported lot number (18f22e0065) matches the lot number for the returned sample.Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.Returned with the sample was 0.025in guidewire.The returned 0.025in guidewire was inspected and appeared typical.Upon return , the iabc bladder was noted withdrawn through the teflon sheath and the teflon sheath was noted on the iabc bladder membrane.The distal end of the teflon sheath was at approximately 6cm from the iabc distal tip; liquid blood/fluid was noted within the sheath sidearm.Buckling to the teflon sheath extrusion was noted approximately from 4.6cm to 14.8cm from the distal end of the teflon sheath.The one way valve was tethered to the iabc short driveline tubing.The exposed portion of the bladder was fully unwrapped.A kink was noted to the central lumen at approximately 5.2cm from the iabc distal tip.Numerous bends were noted on the catheter; the locations were 3.4cm, 26.3cm, 33cm, and 60cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample; no blood was noted within the helium pathway.Since the iabc bladder was noted withdrawn through the teflon sheath and buckling to the sheath, an in-service has been requested to review the instructions for use (ifu) with the customer.The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 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.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 one-way valve was connected to the short driveline tubing and vacuum was pulled on the iabc.While maintaining the vacuum, the sheath was moved from the bladder and towards the bifurcate without difficulty.The bladder appeared typical; no damage or abnormalities were noted to the bladder.The iabc was leak tested and no leaks were detected.Full inflation was achieved.The device passed the leak test.The returned 0.025in guidewire was back loaded through the iabc distal tip.The guidewire met resistance at approximately 2.3cm and 3.4cm; the guidewire could not advance at approximately 5.1cm from the iabc distal tip due to the previously noted kink.Some blood was noted on the guidewire.The guidewire was front loaded through the iabc luer.The guidewire could not advance at approximately 3.8cm from the iabc luer due to a blocked central lumen.Some blood was noted on the guidewire.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 iab "kinked" is confirmed.The intra-aortic balloon catheter (iabc) was returned with a kink and multiple bends to the central lumen.Resistance was noted upon loading a guidewire into the iabc central lumen and the damaged iabc can result in similar alarms seen from the reported complaint.Additionally, the returned iabc bladder was found withdrawn through the teflon sheath and buckling was noted to the teflon sheath extrusion.This indicates the iabc was not removed per the instruction for use (ifu) and could result in damage to the device.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 bends and kink.The root cause of the complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.

• 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: 17666312
• MDR Text Key: 322448404
• Report Number: 3010532612-2023-00490
• 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: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F22E0065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2022
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 71 KG