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

Model Number	IPN915325
Medical Device Problem Codes	Inflation Problem (1310); Biocompatibility (2886); Misassembly by Users (3133); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Right femoral access- no difficulty.Pump turned on 5-6 times then immediately error with red "helium loss".Console was switch out for a new console- same error persisted.Director contacted and came in to assist-director called teleflex hotline spoke with rep.Rep suggested to switch ekg cables- we did this - error still persisted.Rep asked us to turn on pump and during the 5-6 inflations (prior to the error shutting pump off) to see if we could see on fluoro if the balloon was indeed inflating.It was hard to tell but it looked like the balloon was not properly inflating.Rep requested facetime the hotline and rep did not like the "spikes" on the console screen and wanted to see the insertion site- rep doubted the color of the sheath saying we are not using a proper teleflex arrow balloon pump sheath.Director proceeded to show rep an unopened sheath that matched what was in the patient.Then it was decided to put in a new balloon, scrub rn went through the prepping technique with hotline- rep advised we are prepping balloons 100% accurately.Once the new balloon was inserted, new balloon worked properly.Hotline call was ended.

• 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: 50438040
• Report Number: 50438040
• Device Sequence Number: 10281763
• Product Code: DSP
• UDI-Device Identifier: 10801902161977
• UDI-Public: (01)10801902161977
• 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): 06/02/2026
• Report Date (Section F): 06/02/2026

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: IPN915325
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F25J0111
• 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: 08/25/2026
• 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: Male
• Date Report Sent to FDA: 06/02/2026