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.

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

(b)(4).Returned for investigation were the iab pump parts including the pump assembly , interface block assembly, pcs assembly, augmentation valve assembly and a condensation bottle.The intra-aortic balloon catheter (iabc) in question was not returned for the investigation.Visual inspection of the returned iab pump parts was performed.Dried blood was noted inside the bellow port, the interface block assembly tubing, the augmentation valve assembly tubing and the condensation bottle.Liquid blood/fluid was also noted within the pcs assembly tubing.Note: blood can only enter the iabp from an intraaortic balloon catheter (iabc) that develops a leak.The ifu states: "intra-aortic balloon membrane perforation may occur during iabp therapy.The occurrence and severity of the iab perforation is unpredictable and may be due to patient physiology, accidental contact with a sharp instrument or by contact with calcified plaque resulting in membrane surface abrasion and eventual perforation.Large perforations are rare.Small perforations can result in asymptomatic release of gas.Perforation can cause blood to appear in the balloon catheter and driveline tubing." the specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.The reported complaint that "there was what appeared to be bright red blood in the gas tubing" is confirmed.During the investigation, dried/liquid blood was noted within the returned intra-aortic balloon pump (iabp) parts.The only cause for blood backup into the iab pump is from a catheter leak; however, the intra-aortic balloon catheter (iabc) in question was not returned for the investigation.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the blood backup into the iab pump.The root cause of the complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.

• 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
• 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,Followup
• Report Date: 03/04/2024

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 Catalogue Number: IAB-05830-U
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 04/23/2024; 08/20/2024
• Supplement Dates FDA Received: 04/24/2024; 08/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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.; N/A.
• Patient Sex: Female