MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ULTRAFLEX IAB: 8FR 50CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-06850-U
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via medwatch "he iabp was turned off and removed on [date redacted].Upon removal it was quickly noticed that the balloon had multiple clots surrounding it and was coiled suggesting the balloon was never fully inflated".No patient injury or consequence reported.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The serial number on the returned sample is bc30142.No lot number was reported.Returned for investigation was a 50cc 8fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in a cardboard box and was in a bio-hazard bag.Upon return , the teflon sheath was noted connected to the hemostasis cuff.The one-way valve was tethered to the short driveline tubing.The bladder was noted wrapped (or considered twisted) near the distal tip.The long arterial pressure tubing was noted connected to the iabc luer.Bends to the iabc central lumen were noted at approximately 33cm and 61.5cm from the iabc distal tip.A dried yellow media was noted on the teflon sheath and on the exterior of the cath-gard.Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0065in-0.0071in and was within specification of process document.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 in accordance with testing methods from manufacturing procedure.During the leak test, the bladder did not fully inflate.The middle portion of the bladder had inflated but the proximal and distal portion of the bladder would not fully unwrap and was consistent with being twisted.No leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 33.4cm and 61.6cm from the iabc distal tip which are the locations of the previously noted bends.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 that "the balloon was never fully inflate" is confirmed.During the investigation the distal and proximal portion of the iabc bladder was noted twisted and the bladder would not fully inflate or unwrap 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 twisted bladder.The probable root cause of the complaint is manufacturing related.A corrective and preventive action (capa) has been initiated to further investigate the issue.
Event or Problem Description
It was reported via medwatch "he iabp was turned off and removed on [date redacted].Upon removal it was quickly noticed that the balloon had multiple clots surrounding it and was coiled suggesting the balloon was never fully inflated".No patient injury or consequence reported.The patient's current condition is reported as "unknown".

• Brand Name: ARROW ULTRAFLEX IAB: 8FR 50CC
• 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: 20461594
• Report Number: 3010532612-2024-00873
• Device Sequence Number: 7793872
• Product Code: DSP
• UDI-Device Identifier: 10801902144192
• UDI-Public: (01)10801902144192(11)230310(17)250228(10)18F23C0015(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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: 02/28/2025
• Device Catalogue Number: IAB-06850-U
• Device Lot Number: 18F23C0015
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2023
• 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