MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; System, balloon, intra-aortic and control

Model Number	IPN915324
Medical Device Problem Codes	Image Display Error/Artifact (1304); Inflation Problem (1310); Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Access right femoral - no complication.Pump inserted without difficulty.Pumped turned on for about 20 pumps, ao waveform did not look like a typical iabp "[intra-aortic balloon pump]" waveform.Red error "helium loss" pump stopped.Teleflex hotline called "[redacted]".Hotline had us check all connections and look under fluoro the position of the balloon.We attempted to turn pump back on and the balloons distal tip did not look to be inflating.Manual inflation was the next suggestion from the hotline.We aspirated on the helium line (no blood present) and we manually inflated balloon.No difficulty.We saw the balloon under fluoro fully inflate.Turned pump back on and red error "helium loss" still persisted.At that time, we decided to switch balloon out for another 30cc iabp ((b)(6) lot: 18f25h0103).Second balloon went in without difficulty.Pumped for about 2 minutes but under fluoro did not look to be fully inflated (distal tip not inflating).Pump was paused and a pullback/ manual inflation was performed per hotline.Pump restarted.Under fluoro balloon fully inflated and working properly without alarm.Initial balloon was saved.Manufacturer response for system, balloon, intra-aortic and control, arrow (per site reporter).Service member was present at our facility for several days.Found no issues with our set up, staff, or equipment.Was unable to watch an iabp procedure while here.No attempt to rectify the situation as it is -- only suggested we move to a more expensive and unnecessary medical device.Service rep that had been present contacted as soon as this event occurred and stated, "we will follow up with the hot line personnel." manufacturer response for system, balloon, intra-aortic and control, arrow (per site reporter).Service member was present at our facility for several days.Found no issues with our set up, staff, or equipment.Was unable to watch an iabp procedure while here.No attempt to rectify the situation as it is -- only suggested we move to a more expensive and unnecessary medical device.Service rep that had been present contacted as soon as this event occurred and stated, "we will follow up with the hot line personnel.".

• Brand Name: ARROW
• Common Device Name: System, balloon, intra-aortic and control
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 50508445
• Report Number: 50508445
• Device Sequence Number: 18485724
• Product Code: DSP
• UDI-Device Identifier: 10801902161960
• UDI-Public: (01)10801902161960
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/05/2026
• Report Date (Section F): 06/05/2026

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
• Operator of Device: Health Professional
• Device Model Number: IPN915324
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F25H0104
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 06/05/2026