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

Catalog Number	IAB-05840-U
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that approximately 60 hours into patient being on the pump, the balloon ruptured.As a result, the catheter was removed.A 2nd catheter was not inserted as the patient no longer needed iabp therapy.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that approximately 60 hours into patient being on the pump, the balloon ruptured.As a result, the catheter was removed.A 2nd catheter was not inserted as the patient no longer needed iabp therapy.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).No serial number was reported.The serial number on the returned sample is mg20072.Returned for investigation was a 40cc 8.0fr ultra intra-aortic balloon catheter (iabc) without the original packaging.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; dried blood was noted within the inflation driveline tubing.The supplied arterial pressure tubing was noted connected to the iabc luer.The iabc bladder was fully unwrapped.Bends to the iabc central lumen were noted at approximately 25.2cm and 29.5cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was noted within the bladder/helium pathway.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 failed.A vacuum was pulled on the one-way valve, and it immediately lost pressure.This was repeated five separate times with similar results.The one-way valve was properly cleaned and tested again; the one-way valve 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 catheter's central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.The iabc was leak tested and a leak was immediately detected from the bladder membrane.Under microscopic inspection, abrasions were observed around the location of the leak site from approximately 21.5cm to 21.8cm from the iabc distal tip.A full thickness abrasion to the bladder was confirmed at approximately 21.8cm 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 25.1cm and 29.6cm 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 were noted.The guidewire was front loaded through the iabc luer.Resistance was noted at approximately 49.8cm and 52.2cm 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.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 "balloon rupture" 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.

• Brand Name: 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17625009
• Report Number: 3010532612-2023-00482
• Device Sequence Number: 6084191
• Product Code: DSP
• UDI-Device Identifier: 00801902010759
• UDI-Public: 00801902010759
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K000729
• 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): 08/11/2023

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: 12/31/2024
• Device Catalogue Number: IAB-05840-U
• Device Lot Number: 18F23A0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• 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
• Patient Sex: Unknown