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	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
After getting informed consent, the patient was prepped and draped in the usual sterile fashion.Coronary angiography was performed using access obtained in the right radial artery.The right femoral area was infiltrated with lidocaine.A swan-ganz catheter was then advanced via the right femoral vein under fluoroscopic guidance to the right pulmonary capillary wedge position.Placement of an iabp was done through the right femoral artery.When it was time to use the iabp fiberoptix, the device won't calibrate.Physician requested another similar device and they were able to proceed with no further issues.No patient harm.Manufacturer response for system, balloon, intra-aortic and control, arrow (per site reporter).Given to field representative by ccl manager.

• 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: 20180330
• Report Number: 20180330
• Device Sequence Number: 18375538
• Product Code: DSP
• UDI-Device Identifier: 10801902167733
• UDI-Public: (01)10801902167733(17)241231(10)18F23A0026
• 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): 03/12/2024
• Report Date (Section F): 03/13/2024

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: 18F23A0026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2024
• 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: 2 MO
• Patient Sex: Male
• Patient Weight: 2 KG
• Date Report Sent to FDA: 03/13/2024