MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN039787

Device Problem Material Twisted/Bent (2981)

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

Event Date 09/30/2022

Event Type  malfunction  

Event Description

It was reported that "the staff called for help with a dampened ap waveform.The waveform is very narrow, and all of the pressures are reading within 10mm of each other.Staff said they have drawn blood back from the central lumen with good return, and the lumen flushed easily.The staff then said that this is a fiberoptic iab, but the fos was not working.Upon checking it was noted that the fos sensor was recessed.There is a very short duration of inflation with the patient hr around 105.The ap waveform is very narrow, but there is a small "bump" from what appears to be systole.There appears to be no augmentation from the balloon.Staff switch the mode of operation to "operator".Timing was adjusted using the highlight on the ekg and safe timing settings.This widened the duration of inflation on the bpw.The bpw now has a totally squared-off plateau and obvious widening to the deflation artifact as well.The pump also now started to alarm for "high pressure"".Additional information states that "a severe kink was indicated by the bpw morphology.They discussed placing a pillow under the hip and traction on the catheter as positioning techniques.When these steps were taken, the alarms became more frequent and persistent".Further information states that the iab catheter was then removed and replaced.The secondary iab catheter was inserted at the same insertion site.The patient status is reported as "fine".

Manufacturer Narrative

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

Event Description

It was reported that "the staff called for help with a dampened ap waveform.The waveform is very narrow, and all of the pressures are reading within 10mm of each other.Staff said they have drawn blood back from the central lumen with good return, and the lumen flushed easily.The staff then said that this is a fiberoptic iab, but the fos was not working.Upon checking it was noted that the fos sensor was recessed.There is a very short duration of inflation with the patient hr around 105.The ap waveform is very narrow, but there is a small "bump" from what appears to be systole.There appears to be no augmentation from the balloon.Staff switch the mode of operation to "operator".Timing was adjusted using the highlight on the ekg and safe timing settings.This widened the duration of inflation on the bpw.The bpw now has a totally squared-off plateau and obvious widening to the deflation artifact as well.The pump also now started to alarm for "high pressure".Additional information states that "a severe kink was indicated by the bpw morphology.They discussed placing a pillow under the hip and traction on the catheter as positioning techniques.When these steps were taken, the alarms became more frequent and persistent".Further information states that the iab catheter was then removed and replaced.The secondary iab catheter was inserted at the same insertion site.The patient status is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The serial number (b)(6) recorded on the complaint report matches the serial number on the returned sample.Returned for investigation was a 40cc 8.0fr fos intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in the supplied return kit and was inside a biohazard bag.Upon return, the distal end of the teflon sheath was noted at approximately 16.9cm from the iabc distal tip; clear fluid was noted in the sheath sidearm.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.Bends were noted to the iabc at approximately 5cm, 20.5cm and 42.7cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned iabc; no blood was noted within the helium pathway.Upon return, the fos yellow jacket cabling was noted cut near the iabc bifurcate.The fos connector and cal key were not returned.According to the event details "it was noted that the fos sensor was recessed".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.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 multiple bends to the central lumen and resistance was noted at each location loading a guidewire into the iabc central lumen.The damaged iabc can result in similar alarms seen from the reported complaint.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 on the central lumen.The root cause of the bends to the central lumen is undetermined.No further action required at this time.This will be monitored for any developing trends.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15627126
• MDR Text Key: 304689009
• Report Number: 3010532612-2022-00432
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10801902145717
• UDI-Public: 10801902145717
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

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 Expiration Date: 02/28/2024
• Device Model Number: IPN039787
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F22C0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 11/17/2022
• Supplement Dates FDA Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2022
• 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: 25 YR
• Patient Sex: Male