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

Model Number	IPN915319
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that the iab ruptured.As a result, the iab was removed and therapy was discontinued.The patient is stable on minimal medication at time of event.There is no report of patient complications, serious injury or death.The patient status is reported as "fine".
Additional 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 a sealed bio-hazard bag.Upon return, the distal end of the teflon sheath was noted at approximately 27.2cm from the iabc distal tip; liquid blood was noted within the sheath sidearm.The one-way valve was tethered to the short driveline tubing.The iabc bladder was fully unwrapped.A bend to the iabc central lumen was noted at approximately 4.7cm from the iabc distal tip.Blood was noted on the exterior surfaces of the returned iabc as well as within the 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.The bladder thickness was measured at six points with measurements ranging from 0.0057in-0.0061in.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.The cal key and fos were connected to the iabp.The cal key was recognized.The pump status displayed "pl" pressure limit, indicating a possible partial broken fiber.The fiber was inspected; however, no fiber breaks were able to be identified.The catheter was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.The iabc was leak tested.A leak was immediately detected from the bladder membrane.Under microscopic inspection, abrasions were observed around the location of the leak site.A full thickness abrasion to the bladder was confirmed at approximately 19.1cm from the iabc distal tip and the appearance was 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 5.4cm from the iabc distal tip.The guidewire was able to advance through the central lumen.No blood or debris were noted.The guidewire was front loaded through the iabc luer.Resistance was noted at approximately 77.4cm from the iabc luer end.The guidewire was able to advance through the 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 risk is acceptable.This will be monitored for any developing trends.The reported complaint of iab leak suspected 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.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that the iab ruptured.As a result, the iab was removed and therapy was discontinued.The patient is stable on minimal medication at time of event.There is no report of patient complications, serious injury or death.The patient status is reported as "fine".

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16286739
• Report Number: 3010532612-2023-00070
• Device Sequence Number: 6785846
• Product Code: DSP
• UDI-Device Identifier: 10801902167733
• UDI-Public: 10801902167733
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K021462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: IPN915319
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F22K0015
• 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: 01/26/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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