MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC REDIGUARD IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-S840C

Device Problem Material Twisted/Bent (2981)

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

Event Date 07/27/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that the "patient had a balloon in and reached for bottle of water.Soon after they were getting kinking alarms.An hour or so after that they saw blood in the driveline".As a result, the balloon was removed.Another iab was not inserted.No patient harm or injury.The current status of the patient is reported as "deceased".Additional information received states that "the patient had unfortunately passed long after the balloon was removed.The balloon had nothing to do with the patient's death".

Manufacturer Narrative

(b)(4).Additional information received on 23 aug 2023 states that the patient's past medical history included atrial fibrillation, chronic diastolic heart failure, cad, end-stage renal disease on peritoneal dialysis, pulmonary htn, and diabetes.The cause of death was reported as cardiac arrest.No serial number was reported.The serial number on the returned sample is my21020.Returned for investigation was a 40cc 8fr rediguard intra-aortic balloon catheter (iabc) without the original packaging.Upon return, the one-way valve was tethered to the short driveline tubing.The supplied data-scope inflation driveline tubing was connected to the short driveline tubing; dried blood was noted on the interior surfaces of the inflation driveline tubing.The arterial pressure tubing assembly was connected to the iabc luer; clear fluid was noted within the ap tubing.The iabc bladder was fully unwrapped.Numerous kinks to the iabc central lumen were noted at approximately 44cm, 57.9cm and 61.3cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned iabc as well as within the helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0066in-0.0072in and was within specification of process document.The one-way valve was tested and passed.A vacuum was pulled on the one-way valve, and it held for at least 1 minute and then 30 seconds five separate times.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.The iabc was leak tested and a leak was immediately detected from the proximal end of the bladder membrane.Under microscopic inspection, the leak site is consistent with contact from a sharp object and was noted at approximately 26.4cm from the iabc distal tip.No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 44.2cm, 58cm and 61.4cm from the iabc distal tip, which are the locations of the previously noted kinks.The guidewire was able to advance through the central lumen.No blood or debris were noted.The guidewire was front loaded through the iabc luer.Resistance was noted at approximately 23.8cm, 27.2cm and 41cm from the iabc luer, which are the locations of the previously noted kinks.The guidewire was able to advance through the central lumen.No blood or debris were noted.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.The reported complaint that the "blood in the driveline" is confirmed.During the investigation, a puncture to the bladder, consistent with contact from a sharp object, was found near the proximal end of the iabc bladder.No other leaks were detected during functional testing.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 bladder leak.The root cause of the bladder leak is undetermined.The most probable potential cause of how the catheter came into contact with a sharp object is customer handling.No further action required at this time.This will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that the "patient had a balloon in and reached for bottle of water.Soon after they were getting kinking alarms.An hour or so after that they saw blood in the driveline".As a result, the balloon was removed.Another iab was not inserted.No patient harm or injury.The current status of the patient is reported as "deceased".Additional information received states that "the patient had unfortunately passed long after the balloon was removed.The balloon had nothing to do with the patient's death".

• Brand Name: REDIGUARD IAB: 8FR 40CC
• 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: 17586706
• MDR Text Key: 321661324
• Report Number: 3010532612-2023-00475
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002679
• UDI-Public: 00801902002679
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981660
• 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: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F22M0013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2022
• 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