MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-06840-U
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "during a routine ward inspection, the patient was observed changing position independently.The catheter was disinfected, and the external portion was adjusted appropriately.The patient was instructed to strictly immobilize the lower limbs.At approximately 15:58, a small amount of pink frothy fluid was noted in the iabp inflation tubing, raising suspicion of possible balloon rupture.At 17:50, with coordinated efforts from the medical staff, the iabp balloon was removed.The patient reported no discomfort following the procedure.The puncture site on the right lower limb was bandaged with pressure.Currently, the patient's heart rate is 75 beats per minute, and blood pressure is 118/78 mmhg.Close monitoring is ongoing".The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Upon further review, it was determined that this complaint was created in error, thus, the initial mdr submitted on 24 feb 2026 should be retracted.
Event or Problem Description
It was reported "during a routine ward inspection, the patient was observed changing position independently.The catheter was disinfected, and the external portion was adjusted appropriately.The patient was instructed to strictly immobilize the lower limbs.At approximately 15:58, a small amount of pink frothy fluid was noted in the iabp inflation tubing, raising suspicion of possible balloon rupture.At 17:50, with coordinated efforts from the medical staff, the iabp balloon was removed.The patient reported no discomfort following the procedure.The puncture site on the right lower limb was bandaged with pressure.Currently, the patient's heart rate is 75 beats per minute, and blood pressure is 118/78 mmhg.Close monitoring is ongoing".The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Please disgreguard the previous follow up requesting a retraction of this complaint file.This complaint is valid and will remain in process.
Event or Problem Description
It was reported "during a routine ward inspection, the patient was observed changing position independently.The catheter was disinfected, and the external portion was adjusted appropriately.The patient was instructed to strictly immobilize the lower limbs.At approximately 15:58, a small amount of pink frothy fluid was noted in the iabp inflation tubing, raising suspicion of possible balloon rupture.At 17:50, with coordinated efforts from the medical staff, the iabp balloon was removed.The patient reported no discomfort following the procedure.The puncture site on the right lower limb was bandaged with pressure.Currently, the patient's heart rate is 75 beats per minute, and blood pressure is 118/78 mmhg.Close monitoring is ongoing".The patient's current condiion is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint for "possible balloon rupture" is not able to be confirmed.The product was not returned for investigation.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 required at this time.The reported complaint will be monitored for any developing trends.If the product is returned at a later date, a full investigation of the sample will be completed.
Event or Problem Description
It was reported "during a routine ward inspection, the patient was observed changing position independently.The catheter was disinfected, and the external portion was adjusted appropriately.The patient was instructed to strictly immobilize the lower limbs.At approximately 15:58, a small amount of pink frothy fluid was noted in the iabp inflation tubing, raising suspicion of possible balloon rupture.At 17:50, with coordinated efforts from the medical staff, the iabp balloon was removed.The patient reported no discomfort following the procedure.The puncture site on the right lower limb was bandaged with pressure.Currently, the patient's heart rate is 75 beats per minute, and blood pressure is 118/78 mmhg.Close monitoring is ongoing".The patient's current condition is reported as "fine".

• Brand Name: ARROW ULTRAFLEX IAB: 7.5FR 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: 24429652
• Report Number: 3010532612-2026-00155
• Device Sequence Number: 18698852
• Product Code: DSP
• UDI-Device Identifier: 10801902145748
• UDI-Public: (01)10801902145748(11)250423(17)270331(10)18F25D0080(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,Followup
• Report Date (Section B): 01/29/2026

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-06840-U
• Device Lot Number: 18F25D0080
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided; 03/20/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 02/24/2026; 02/24/2026; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2025
• 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