MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 8FR 50CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-06850-U

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 09/01/2023

Event Type  malfunction  

Event Description

Reported as "unable to get an arterial pressure waveform from the catheter".The report states that "they were not able to get an arterial pressure waveform on the pump.They had checked the position of the balloon via tee.The physician stated that it was in good position.I asked if they were able to aspirate blood back from the central lumen.They did not let me know.The surgeon then decided to place the patient back on bypass and remove the balloon.Unsure if they will try to insert another iab".No patient harm or injury.The patient status is reported as "critical".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The reported complaint that "unable to get an arterial pressure waveform from the catheter" is not able to be confirmed.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.

Event Description

Reported as "unable to get an arterial pressure waveform from the catheter".The report states that "they were not able to get an arterial pressure waveform on the pump.They had checked the position of the balloon via tee.The physician stated that it was in good position.I asked if they were able to aspirate blood back from the central lumen.They did not let me know.The surgeon then decided to place the patient back on bypass and remove the balloon.Unsure if they will try to insert another iab".No patient harm or injury.The patient status is reported as "critical".

• Brand Name: ULTRAFLEX IAB: 8FR 50CC
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17746534
• MDR Text Key: 323418866
• Report Number: 3010532612-2023-00536
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10801902144192
• UDI-Public: 10801902144192
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

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
• Device Catalogue Number: IAB-06850-U
• Device Lot Number: 18F23A0075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 10/20/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• 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
• Treatment: N/A.; N/A.
• Patient Sex: Male