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

Catalog Number	IAB-05830-LWS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "iab rupture/abrasion." additional information states that the iab catheter was not replaced due to " patient remained stable without therapy." the patient's current condition is reported as "fine.".
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 30cc 8fr fiberoptix ultra intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in the ups shipping box and was in a sealed biohazard bag.Returned with the sample was supplied 30cc inflation driveline tubing; dried blood was noted within the returned inflation driveline tubing.Upon return, the teflon sheath was noted on the returned iabc.The one-way valve was tethered to the short driveline tubing.A non-teleflex short arterial pressure tubing was noted connected to the iabc luer.The bladder was fully unwrapped.A bend to the iabc central lumen was noted at approximately 5.3cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was also noted within the iabc helium pathway.The fos connector and cal key were examined.The fos gray connector was properly seated in the blue clamshell housing and both retaining tabs were in-tact.The center post of the fos was centered.The blue clamshell housing was examined, and no abnormalities were noted.The cal key was intact.No visual damage or abnormalities were noted to the cal key.The bladder thickness was measured at six points with measurements ranging from 0.0052in-0.0062in and was within specification of process document.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.The cal key and fos were connected to the iabp.The cal key was recognized.The fos was connected and the iabp zeroed the iabc.The pump status displayed "ok" indicating the fiber is fully intact.The iabc central lumen was successfully aspirated and flushed using a 60cc lab-inventory syringe.No blood or debris was noted.The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was immediately detected from the bladder membrane.Under microscopic inspection, abrasions were observed from approximately 7.5cm to 8.1cm from the iabc distal tip; a full thickness abrasion to the bladder was confirmed at approximately 7.7cm from the iabc distal tip and the appearance is consistent with repeated contact with calcified plaque on the aortic wall.No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 5.5cm from the iabc distal tip, which is the location of the previously noted bend.The guidewire was able to advance through the central lumen.No blood or de-bris 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 "iab rupture / abrasion" is confirmed.During investigation, the intra-aortic balloon catheter (iabc) bladder was found with a full thickness abrasion, which allowed blood to enter the helium pathway.The appearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall.No other leaks were detected during functional testing.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 bladder leak.The root cause of the bladder leak is related to patient condition.No further action required at this time.This will be monitored for any developing trends.
Event or Problem Description
It was reported "iab rupture/abrasion".Additional information states that the iab catheter was not replaced due to " patient remained stable without therapy".The patient's current condition is reported as "fine".

• Brand Name: ARROW FIBEROPTIX ULTRA 8 IAB: 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: 20712379
• Report Number: 3010532612-2024-00975
• Device Sequence Number: 21308189
• Product Code: DSP
• UDI-Device Identifier: 00801902034724
• UDI-Public: (01)00801902034724(11)230214(17)250131(10)18F23B0023(21)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K021462
• 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): 10/21/2024

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 Expiration Date: 01/31/2025
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F23B0023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• 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: A2W-CARDIOSAVE-A2W; A2W-CARDIOSAVE-A2W
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 21 KG