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

Model Number	IPN038077
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the catheter was inserted, the pump alarmed for "possible helium leak" after about 2 minutes.Catheter position was confirmed and the balloon inflation rate was decreased to 35cc.The alarm persisted.The triggering mode was in normal sinus rhythm with a hr of 82.As a result, the catheter was removed and a 2nd catheter was inserted at the same insertion site.Therapy then continued normally.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that after the catheter was inserted, the pump alarmed for "possible helium leak" after about 2 minutes.Catheter position was confirmed and the balloon inflation rate was decreased to 35cc.The alarm persisted.The triggering mode was in normal sinus rhythm with a hr of 82.As a result, the catheter was removed and a 2nd catheter was inserted at the same insertion site.Therapy then continued normally.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).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 bladder was fully unwrapped.No bends, kinks or abnormalities were noted to the returned sample.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 0.0063in-0.0070in 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 no leaks were detected.Full inflation was achieved.The device passed the leak test.The iabc was connected to an iabp with a lab-inventory 40cc inflation driveline tubing.The iabc was inserted into the "t" tube and 75mmhg backpressure was applied.The iabc was pumped for a minimum of 30 minutes.There were no alarms triggered.The bladder inflated and deflated completely with each beat.The balloon pressure waveform (bpw) was normal.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.No resistance was noted; the guidewire was able to advance through the central lumen.No blood or debris was noted.The guidewire was front loaded through the iabc luer.No resistance was noted; the guidewire was able to advance through the central lumen.No blood or debris was 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 of iab helium loss alarm is not confirmed.The returned iabc was functionally tested with no leak or abnormalities noted.No alarms were noted during the functional testing.The returned device passed visual and functional test specifications.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.Other remarks: n/a.Corrected data: n/a.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Common Device Name: 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: 16777232
• Report Number: 3010532612-2023-00218
• Device Sequence Number: 7014627
• Product Code: DSP
• UDI-Device Identifier: 00801902136732
• UDI-Public: 00801902136732
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K981660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: IPN038077
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F22E0057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 72 KG