MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-05830-U

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

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

Event Date 03/04/2024

Event Type  Injury  

Manufacturer Narrative

Qn # (b)(4).N/a other remarks: n/a corrected data: n/a.

Event Description

Reported as "failed iab membrane".It was reported that "[user] called to report that they had a iab membrane failure.He said that the iab was placed in the ccl early this morning.The nurse taking care of the patient reported that there was what appeared to be bright red blood in the gas tubing.[user] stated that it was 'quite a lot' of blood.The patient was awaiting ohs in the morning.The surgeon opted to take the patient to the or directly and removed the iab in the or.[user] said that the surgeon said that he was not sure if they would replace the iab.He told her that it depended on how the patient was doing after bypass".No patient harm or injury.The patient status is reported as "fine".Additional information states, "this is a female patient with an acute mi.The patient had 30 cc ultra 8 iab inserted while the patient was in the cath lab.About 8 hours after the catheter was inserted the nurse noted a lot of blood in the gas tubing.Pumping was stopped, the nurse clamped the iab and disconnected the iab from the pump.She next contacted the educator.They contacted the surgeon.The patient had been waiting to go for surgery in the morning.The patient was stable without the pump support.The surgeon decided to take the patient for cabg surgery at this time.They removed the iab in the or without difficulty.The patient returned to the unit post surgery without an iab in place.The patient later had a cardiac arrest in the unit.They were going to try and insert another iab at that time, but the patient expired".At the time of this report, the customer has not returned our requests for additional information.

Manufacturer Narrative

Qn#(b)(4).The reported complaint that "there was what appeared to be bright red blood in the gas tubing" 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 "failed iab membrane".It was reported that "[user] called to report that they had a iab membrane failure.He said that the iab was placed in the ccl early this morning.The nurse taking care of the patient reported that there was what appeared to be bright red blood in the gas tubing.[user] stated that it was 'quite a lot' of blood.The patient was awaiting ohs in the morning.The surgeon opted to take the patient to the or directly and removed the iab in the or.[user] said that the surgeon said that he was not sure if they would replace the iab.He told her that it depended on how the patient was doing after bypass".No patient harm or injury.The patient status is reported as "fine".Additional information states, "this is a female patient with an acute mi.The patient had 30 cc ultra 8 iab inserted while the patient was in the cath lab.About 8 hours after the catheter was inserted the nurse noted a lot of blood in the gas tubing.Pumping was stopped, the nurse clamped the iab and disconnected the iab from the pump.She next contacted the educator.They contacted the surgeon.The patient had been waiting to go for surgery in the morning.The patient was stable without the pump support.The surgeon decided to take the patient for cabg surgery at this time.They removed the iab in the or without difficulty.The patient returned to the unit post surgery without an iab in place.The patient later had a cardiac arrest in the unit.They were going to try and insert another iab at that time, but the patient expired".At the time of this report, the customer has not returned our requests for additional information.

• Brand Name: ULTRA 8 IAB: 8FR 30CC
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18981200
• MDR Text Key: 338661704
• Report Number: 3010532612-2024-00207
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902010742
• UDI-Public: 00801902010742
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-05830-U
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Female