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

Model Number IPN000263

Device Problem No Device Output (1435)

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

Event Date 02/21/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that after the iab was inserted into the patient, the iabp was unable to display the blood pressure waveform.Attempts at adjusting the catheter position and flushing the central lumen were unsuccessful.As a result, a 2nd iab was inserted at the same insertion site.No patient harm or injury.Patient status is reported as "fine".

Event Description

It was reported that after the iab was inserted into the patient, the iabp was unable to display the blood pressure waveform.Attempts at adjusting the catheter position and flushing the central lumen were unsuccessful.As a result, a 2nd iab was inserted at the same insertion site.No patient harm or injury.Patient status is reported as "fine".

Manufacturer Narrative

(b)(4).The serial number ((b)(6)) recorded on the complaint report matches the serial number on the returned sample.The lot number (18f22g0028) reported on the complaint report matches the lot number for the returned sample.Returned for investigation was a 40cc 8.0fr rediguard intra-aortic balloon catheter (iabc) without the original packaging.Upon return, the one-way valve was tethered to the short driveline tubing.The iabc bladder was fully unwrapped.Dried blood was noted on the exterior surfaces of the returned iabc; no blood was noted within the helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0071in-0.0075in.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.An attempt to aspirate and flush the catheter using a 60cc lab-inventory syringe was unable to be successfully completed and pushback was noted.The central lumen was likely blocked by a blood clot.Another attempt to aspirate and flush the catheter was made after passing a guidewire through the central lumen and clearing some of the blood clot; this attempt was also unsuccessful; the blood clot was unable to be fully cleared.The iabc was leak tested.No leaks were detected.Full infl ation was achieved.The device passed the leak test.A lab inventory 0.025in guidewire was front loaded through the iabc luer end.Resistance was noted at approximately 6.6cm, 10.7cm, 36.8cm, and 44.9cm from the iabc luer.The guidewire could not advance at approximately 74.6cm from the iabc luer end.Blood was noted on the guidewire upon removal.The guidewire was back loaded through iabc distal tip.The guidewire could not advance at approximately 9.0cm from the iabc distal tip.Blood was noted on the guidewire upon removal.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 ap waveform poor signal is confirmed.During the investigation, the iabc central lumen aspiration/flushing test was unsuccessful.A blood clot was partially cleared from the central lumen during the guidewire test.The blood built up in the central lumen may have resulted from not maintaining the patency of the arterial line.A blood clot in the central lumen can lead to occlusion and is a potential cause of the reported complaint.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 buildup within the central lumen.The root cause of the complaint is undetermined.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: 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16538537
• MDR Text Key: 311313609
• Report Number: 3010532612-2023-00160
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002679
• UDI-Public: 00801902002679
• 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: 03/09/2023

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 Operator: Health Professional
• Device Model Number: IPN000263
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F22G0028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 03/14/2023
• Supplement Dates Manufacturer Received: 04/28/2023
• Supplement Dates FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2022
• 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