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

Model Number IPN917537

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2022

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 288397501
• Report Number: 3010532612-2022-00096
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902010759
• UDI-Public: 00801902010759
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/04/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 04/22/2022
• Supplement Dates FDA Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1