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

Catalog Number	IAB-05840-U
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "suspected iab abrasion".Additional information states the catheter was removed and not replaced and that " patient will be managed medically".No patient injury or consequence reported.The patients current condition is reported as "fine".
Event or Problem Description
It was reported "suspected iab abrasion".Additional information states the catheter was removed and not replaced and that " patient will be managed medically".No patient injury or consequence reported.The patients current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).Returned for investigation was a 40cc 8fr ultra intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in the ups shipping box and was in a sealed bio-hazard bag.Upon return, the teflon sheath was noted on the returned iabc; liquid blood was noted within the sheath sidearm.The short driveline tubing was noted cut; the remaining length of the short driveline tubing including the one-way valve tethered and one-way valve was not returned with the sample.The distal and proximal portion of the iabc bladder was noted wrapped (or considered twisted); the remaining visible portion of the iabc bladder was noted fully unwrapped.A bend to the iabc central lumen was noted at approximately 33.5cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.No blood was noted within the helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0059in-0.0067in and was within specification of process document.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.A lab inventory short driveline tubing was connected to the iabc bifurcate.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 distal and proximal portions 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 33.6cm 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 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 of iab helium loss alarm is confirmed.During the investigation, the distal and proximal portions of the iabc bladder were noted twisted.During functional testing, the bladder would not fully inflate or unwrap.The twisted bladder could trigger the "helium loss" alarm and cause the reported complaint.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 has been initiated to further investigate the issue.

• Brand Name: ARROW 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20779892
• Report Number: 3010532612-2024-00999
• Device Sequence Number: 9005709
• Product Code: DSP
• UDI-Device Identifier: 00801902010759
• UDI-Public: (01)00801902010759(11)240223(17)260131(10)18F24B0051(21)
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K000729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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: 01/31/2026
• Device Catalogue Number: IAB-05840-U
• Device Lot Number: 18F24B0051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2024
• 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