MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC REDIGUARD IAB: 7FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN915324

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/09/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that "after the operator performed cag+ptca, the iabp was inserted.After the machine was turned on, the alarm showed helium leakage.According to the alarm information, the operator withdrew half of the balloon, and there was blood gushing out of the balloon.Then the new catheter was replaced, and the machine was normal." the 2nd iab was inserted at the same insertion site.No report of patient harm or injury.The patient status is reported as "fine".

Event Description

It was reported that "after the operator performed cag+ptca, the iabp was inserted.After the machine was turned on, the alarm showed helium leakage.According to the alarm information, the operator withdrew half of the balloon, and there was blood gushing out of the balloon.Then the new catheter was replaced, and the machine was normal." the 2nd iab was inserted at the same insertion site.No report of patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).No serial number was reported.The serial number on the returned sample is (b)(6).The lot number (18f21m0017) reported on the complaint report matches the lot number for the returned sample.Returned for investigation was a 30cc 7fr rediguard intra-aortic balloon catheter (iabc) without the original packaging.Upon return, the distal end of the super arrow-flex (saf) sheath was noted at approximately 26.7cm from the iabc distal tip; blood was noted within the sheath sidearm.The one-way valve was tethered to the short driveline tubing.The iabc bladder was fully unwrapped.Kinks to the iabc central lumen were noted at approximately 9.0cm from the iabc luer end, and 48.8cm from the iabc distal tip.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 0.0068in-0.0070in.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 note d.The iabc was leak tested.Multiple leaks were immediately detected from the bladder membrane.Under microscopic inspection, four leak sites were identified consistent with contact from a sharp object and were noted at approximately 5.6cm, 4.9cm, 4.7cm, and 11.5cm 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 9.1cm, 48.9cm, and 75.8cm from the iabc distal tip.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 9.0cm, and 35.9cm from the iabc luer.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 risk is acceptable.This will be monitored for any developing trends.The reported complaint of iab blood in helium pathway is confirmed.During the investigation, multiple punctures consistent with contact fro m a sharp object, were found on the iabc bladder, which allowed blood to enter the helium pathway.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.

• Brand Name: REDIGUARD IAB: 7FR 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16468048
• MDR Text Key: 310601679
• Report Number: 3010532612-2023-00144
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10801902161960
• UDI-Public: 10801902161960
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: IPN915324
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F21M0017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2021
• 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
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 62 KG