MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-06830-U
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the catheter could not pass through the sheath and the supporting force was insufficient".Additional information states that the iab catheter was removed and replaced.No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "the catheter could not pass through the sheath and the supporting force was insufficient".Additional information states that the iab catheter was removed and replaced.No patient injury or consequence reported.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "the catheter could not pass through the sheath and the supporting force was insufficient".Additional information states that the iab catheter was removed and replaced.No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4) the serial number on the returned sample is (b)(6).Returned for investigation was a 30cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) with the original packaging box that matches the serial number for the returned sample.The sample was returned in a cardboard box and was loosely packed within the original packaging carton.Upon return, the peel away sheath was not-ed on the iabc.The stylet was noted inserted within the iabc central lumen.The one-way valve was tethered and connected to the short driveline tubing.The bladder was fully unwrapped.The sheath in question was not returned with the sample.No blood was noted on the exterior surfac-es of the returned sample.No obvious blood was noted within the helium pathway.The customer photo was reviewed.The photo shows an opened iab insertion kit and the iab catheter.The bladder thickness was measured at six points with measurements ranging from 0.0054in-0.0061in and was within specification of process document.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 according to quality system document.The stylet was removed from the iabc central lumen without any diffi-culty.The catheter's central lumen was aspirated and flushed using a 60cc lab inventory syringe.No blood or debris was noted.The iabc was leak tested in accordance with testing methods from manufacturing procedure.No leaks were detected.Full inflation was achieved.The device passed the leak test.A lab inventory 0.025in guidewire was back loaded through iabc distal tip.No resistance was noted; the guidewire was able to advance through the central lumen.No blood or debris was noted.The returned iabc could not be advanced through a lab inventory sheath due to the returned state of the device.Upon return, the bladder was fully unwrapped.As a result, difficulty may occur if the iabc is attempted to be inserted through a sheath with the bladder loosely wrapped.A device history record (dhr) review was conducted for the lot num-ber with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint that the "catheter could not pass through the sheath" is not confirmed.The sheath in question was not returned for investigation.An iab catheter was received for the investigation with no damage or abnormalities noted.During the investigation, the returned intra-aortic balloon catheter (iabc) passed dimensional and functional test specifications.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action is required at this time.

• Brand Name: ARROW ULTRAFLEX IAB: 7.5FR 30CC
• 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: 22630476
• Report Number: 3010532612-2025-00693
• Device Sequence Number: 9166636
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: (01)00801902003751(11)250124(17)261231(10)18F25A0057(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K000729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2025

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 Catalogue Number: IAB-06830-U
• Device Lot Number: 18F25A0057
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 08/20/2025; 12/29/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/22/2025; 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2025
• 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