MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC INTRA-AORTIC BALLOON CATHETER KIT; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN917537
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).There is an investigation ongoing into this reported complaint.A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.
Event or Problem Description
It was reported that the staff received a high-pressure alarm.There were "no obvious kinks or evidence of compromised catheter.Pump restarted, and high-pressure alarm triggered again a few minutes later." it was noted that there was a light speck of blood observed in the gas driveline.As a result, the pump was stopped, and the catheter was removed by the surgeon.Patient is now hemodynamically stable but dependent on inotropes and invasive ventilation.
Additional Manufacturer Narrative
Qn# (b)(4).Upon further review it was determined that no surgical cut down was performed therefore the reportability of this complaint has been updated to reportable malfunctions.The product was not returned for investigation.The reported complaint of iab blood in helium pathway is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.
Event or Problem Description
It was reported that the staff received a high-pressure alarm.There were "no obvious kinks or evidence of compromised catheter.Pump restarted, and high-pressure alarm triggered again a few minutes later." it was noted that there was a light speck of blood observed in the gas driveline.As a result, the pump was stopped, and the catheter was removed by the surgeon.Patient is now hemodynamically stable but dependent on inotropes and invasive ventilation.

• Brand Name: INTRA-AORTIC BALLOON CATHETER KIT
• 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: kaylia pen ; 16 elizabeth drive; chelmsford, MA 01824
• MDR Report Key: 13978700
• Report Number: 3010532612-2022-00096
• Device Sequence Number: 17502696
• Product Code: DSP
• UDI-Device Identifier: 00801902010759
• UDI-Public: 00801902010759
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K000729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: IPN917537
• Device Catalogue Number: IAB-05840-U
• Device Lot Number: 18F21K0096
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• 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