MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW REDIGUARD IAB: 7FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-S730C
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the catheter was inserted into the patient.After 1 day of treatment, the pump alarm helium leakage, and blood was found, which was determined to be due to the balloon rupture.The catheter was immediately removed".Additional information states the iab catheter was removed and not replaced.No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the catheter was inserted into the patient.After 1 day of treatment, the pump alarm helium leakage, and blood was found, which was determined to be due to the balloon rupture.The catheter was immediately removed".Additional information states the iab catheter was removed and not replaced.No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(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.
Additional Manufacturer Narrative
(b)(4).The serial number on the returned sample is (b)(6).Returned for investigation was a 30cc 7fr rediguard intra-aortic balloon catheter (iabc) with the original packaging box that does not match 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 super arrow-flex (saf) sheath was noted on the iabc bladder; the visible portion of the bladder was unwrapped.The one-way was tethered to the short driveline tubing.The supplied 30cc driveline tubing was connected to the short driveline tubing.Dried blood was noted on the exterior surfaces of the re-turned sample.No obvious blood was noted within the helium pathway.The iabc bladder was noted withdrawn through the saf sheath which indicates the iabc was not removed from the pa-tient correctly per the instructions for use (ifu).As a result, an in-service has been requested to review the instructions for use (ifu) with the customer.The instructions for use (ifu) states:"do not remove arrow iab through hemostasis sheath introducer or hemostasis device.Once un-wrapped (unfurled), balloon profile will not allow passage through the sheath and attempted re-moval in this manner may result in arterial tearing, dissection or balloon damage.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 one-way valve was connected to the short driveline tubing and a negative vacuum was pulled on the returned iabc.While maintaining the vacuum, the saf sheath was moved towards the iabc bifurcate with some force.Upon removal, no damage was noted to the bladder.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 ad-vance 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 manu-facturing specifications prior to release.The reported complaint for "balloon rupture" is not confirmed.The returned intra-aortic balloon catheter (iabc) passed functional test specifications.The returned iabc bladder was fully intact with no abnormalities noted.During the investigation, the iabc fully inflated, and no leaks were detected.Unrelated to the reported complaint, the returned iabc bladder was found withdrawn through the saf sheath.This indicates the iabc was not removed per the instruction for use (ifu) and could result in damage to the device.An in-service has been requested to review the instruc-tions for use (ifu) with the customer.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 fur-ther action is required at this time.
Event or Problem Description
It was reported "the catheter was inserted into the patient.After 1 day of treatment, the pump alarm helium leakage, and blood was found, which was determined to be due to the balloon rupture.The catheter was immediately removed".Additional information states the iab catheter was removed and not replaced.No patient injury or consequence reported.The patient's current condition is reported as "fine".

• Brand Name: ARROW REDIGUARD IAB: 7FR 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: 22576690
• Report Number: 3010532612-2025-00674
• Device Sequence Number: 13153258
• Product Code: DSP
• UDI-Device Identifier: 00801902002686
• UDI-Public: (01)00801902002686(11)240801(17)260731(10)18F24G0123(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K981660
• 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): 06/26/2025

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 Expiration Date: 07/31/2026
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F24G0123
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 08/15/2025; 12/29/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/21/2025; 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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
• Patient Sex: Unknown