MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	IPN915319
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient underwent successful pci (percutaneous coronary intervention) of the mid right coronary artery with balloon angioplasty 2 days prior.This time, patient underwent iabp (intra-aortic balloon pump) insertion prior to a scheduled cabg (coronary artery bypass graft).Per cardiac interventionist notes: after informed consent, the patient was brought to the ccl (cardiac catheterization lab) in stable condition, draped and prepped in the usual manner.The right femoral artery was accessed under ultrasound guidance with a micropuncture needle and wire.A right femoral angiogram is performed in the rao (right anterior oblique) projection to verify appropriate access location.The sheath is exchanged for the 8-french iabp sheath.The iabp is then advanced under fluoroscopic guidance to the level of the aortic knob.After prepping the balloon pump, counterpulsation is initiated.Although the balloon is visually seen to inflate under fluoroscopy, there is continued alarming of the console.Therefore, the balloon and sheath were removed over wire and a new iabp is advanced under fluoroscopic guidance.Counterpulsation is initiated and balloon inflation is verified under fluoroscopy.There is no further alarming from the console and there is adequate augmentation of mean arterial pressure.Conclusion: successful advancement of iabp via right femoral artery under fluoroscopic guidance.The patient was then brought to the operating room for a planned/scheduled cabg.Manufacturer response for system, balloon, intra-aortic and control, arrow (per site reporter).No response from manufacturer.Device was given to field representative.

• 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: 21168018
• Report Number: 21168018
• Device Sequence Number: 11831121
• Product Code: DSP
• UDI-Device Identifier: 10801902167733
• UDI-Public: (01)10801902167733(17)260331(10)18F24C0193
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2024
• Report Date (Section F): 11/26/2024

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: IPN915319
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F24C0193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2025
• 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
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 114 KG
• Date Report Sent to FDA: 11/26/2024