MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW FIBEROPTIX ULTRA 8 IAB SC: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-05830-LWS-SC
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "iab rupture".What was done after the notice of the rupture to continue therapy is unknown.No patient injury or consequence reported.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "iab rupture".What was done after the notice of the rupture to continue therapy is unknown.No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 30cc 8fr fiberoptix ultra (sc) intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in a cardboard box and was in a sealed bio-hazard bag.Upon return, the iabc bladder was noted withdrawn through the teflon sheath and the sheath was noted on the section of the iabc bladder membrane; liquid blood/fluid was noted within the sheath sidearm.The one-way valve was tethered to the short driveline tubing.The sup-plied 30cc inflation driveline tubing was connected to the short driveline tubing; dried/liquid blood was noted within the inflation driveline tubing.A non-teleflex long arterial pressure tubing was connected to the iabc luer; liquid blood was noted within the ap tubing.The visible section of the bladder was fully unwrapped.Dried blood was noted on the exterior surfaces of the returned sample.Dried/liquid blood was noted within the helium pathway.No visual damage was noted to the returned sample.The fos (sc) connector was examined.The fos white connector was properly seated in the blue clamshell housing.The center post of the fos was centered.The blue clamshell housing was examined, and no abnormalities were noted.The customer submitted photos.The first photo shows the iabc serial number label.The serial number noted in the photo matches the serial number reported on the complaint report and the returned sample.The photos show the recorder strips with "high pressure" alarm.The photo shows the recorder strip.The photo shows the recorder strip with "possible helium loss 3" alarm.The photo shows the iab pump serial number information.The iabc bladder was noted withdrawn through the teflon sheath, which indicates the iabc was not re-moved from the patient correctly per the instructions for use (ifu).As a result, 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 de-vice.Once unwrapped (unfurled), balloon profile will not allow passage through the sheath and at-tempted 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 according to quality system document.The fos (sc) connector was connected to the iabp.The pump status displayed "not connected".Upon further checking, the fiber was found broken at approximately 1.9cm from the iabc distal tip.The full length of the fiber was confirmed present with no other notable breaks.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, which indicates a cross-over leak between the iabc central lumen and helium pathway.The iabc distal tip and iabc luer end blocked off.Then the oneway valve was connected to the short driveline tubing and a vacuum was pulled on the returned iabc.While maintaining the vacuum, the teflon sheath was moved from the iabc bladder and towards the bifurcate without any difficulty.Upon removal of the sheath, the iabc bladder appeared typical.No visual damage or abnormalities noted to the returned sample.The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was immediately detected from the iabc distal tip and iabc luer end.Upon cleaning the device, the iabc central lumen was noted broken near the bifurcate at approximately 8.8cm from the luer end.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 could not advance at approximately 68.2cm from the iabc, which is the location of the previously noted broken central lumen.No blood or debris was noted.The guidewire was front loaded through the iabc luer.The guidewire could not advance at approximately 8.8cm from the iabc luer, which is the location of the previously noted broken central lumen.No blood or debris was noted.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 for "blood in helium driveline" is confirmed.During the investigation, the intra-aortic balloon catheter (iabc) central lumen was noted broken near the iabc bifurcate.The broken central lumen allowed blood to enter the helium pathway.Unrelated to the reported complaint, the returned iabc bladder was found withdrawn through the teflon sheath.This indicates the user did not follow 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 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 broken central lumen.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: ARROW FIBEROPTIX ULTRA 8 IAB SC: 8FR 30CC
• Common Device Name: 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22090873
• Report Number: 3010532612-2025-00451
• Device Sequence Number: 7866155
• Product Code: DSP
• UDI-Device Identifier: 10801902218909
• UDI-Public: (01)10801902218909(11)250210(17)270131(10)18F25B0057(21)
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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 Catalogue Number: IAB-05830-LWS-SC
• Device Lot Number: 18F25B0057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown