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

Model Number IPN000254

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/20/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

Reported as "iab rupture, blood noted in helium driveline".The report states that the pump alarmed for "helium loss 2".Blood was noted in the driveline near the groin site.As a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.Patient status reported as "fine".

Manufacturer Narrative

(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 in sealed bio-hazard bags.Upon return, the one-way valve was tethered to the short driveline tubing.The supplied 40cc inflation driveline tubing was noted connected to the iabc short driveline tubing; liquid blood was noted within the inflation driveline tubing.The short/long arterial pressure tubing was noted connected to the iabc luer end; clear fluid was noted within the ap tubing.The iabc bladder was fully unwrapped.The iabc distal tip was noted within the iabc bladder membrane; it could not be determined during visual inspection if the distal tip/iabc bladder was damaged.Numerous bends to the iabc central lumen were noted at approximately 2.2cm, 4.8cm, 30.8cm and 66.3cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned iabc.Dried/liquid blood was 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 intact.The center post of the fos was centered.The blue clamshell housing was examined, and no abnormalities were noted.The cal key was intact.According to the product complaint form submitted, the event insertion type included a "sheath", and no sheath was returned with the iabc.The iabc may have been removed through a sheath during the event or after the device removal.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 bladder thickness was measured at six points with measurements ranging from 0.0054in-0.0061in 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 in accordance with quality system document q-96.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.Upon further inspection of the iabc distal tip, it was noted that the iabc distal tip was separated and no longer attached to the iabc bladder.Upon microscopic inspection, no other damage or abnormalities were noted to the distal tip of the iabc bladder.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.The iabc was leak tested using the lt-l-015 in accordance with testing methods from manufacturing procedure 21-7214 rev.15.A leak was immediately detected from the distal tip of the bladder membrane.The leak noted from the distal tip of the bladder is consistent with the previously noted bladder detachment from the iabc distal tip.The iabc was leak tested again, with the distal tip of the bladder clamped off, and a leak was immediately detected from the bladder membrane.Under microscopic inspection, abrasions were observed around the location of the leak at approximately from 16.4cm to 17.6cm from the iabc distal tip.A full thickness abrasion to the bladder was confirmed at approximately 16.7cm 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.Furthermore, after thoroughly cleaning of the device, further inspection of the iabc distal tip and distal tip of the bladder was performed.Under microscopic inspection, no other damage or abnormalities were noted to the distal tip of the iabc bladder.No obvious damage or abnormalities were noted to the iabc distal tip.Evidence of previous adherence of the iabc bladder to the iabc distal tip was noted.Due to the nature of the event and the event insertion type included a "sheath", the most probable cause of the blood entering the helium pathway is the leak site from abrasions/contact with calcified plaque.The iabc may have been removed through a sheath during the event or after the device removal, which likely caused the bladder to detach/separate from the iabc distal tip.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 30.5cm and 66.5cm from the iabc distal tip, which are the locations of the previously noted bends.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.Resistance was noted at approximately 16cm and 51.2cm from the iabc luer, which are the locations of the previously noted bends.The guidewire was able to advance through the central lumen.No blood or debris was noted.The reported complaint that the "iab rupture, blood noted in helium driveline" is confirmed.The intra-aortic balloon catheter (iabc) bladder had a full thickness abrasion, which caused the blood to enter the helium pathway.The appearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall.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 Description

Reported as "iab rupture, blood noted in helium driveline".The report states that the pump alarmed for "helium loss 2".Blood was noted in the driveline near the groin site.As a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.Patient status reported as "fine".

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16914735
• MDR Text Key: 315103204
• Report Number: 3010532612-2023-00252
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: 00801902007247
• 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: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: IPN000254
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F22A0036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2022
• 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 Sex: Female