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

Catalog Number	IAB-S840C
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that after the iab was inserted, iabp therapy was initiated.After 1 minute of pumping, it alarmed for "possible helium leakage".The catheter and inflation rate was adjusted to 30cc but the alarmed persisted.As a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".
Event or Problem Description
It was reported that after the iab was inserted, iabp therapy was initiated.After 1 minute of pumping, it alarmed for "possible helium leakage".The catheter and inflation rate was adjusted to 30cc but the alarmed persisted.As a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of iab "possible helium leakage" was not confirmed.The customer returned a 40cc 8.0fr rediguard intra-aortic balloon catheter (iabc) with the original packaging box that matches the serial number on the returned sample (inp-2, inp-3) for investigation.The sample was returned in a cardboard box and was loosely packed within the original packaging carton (inp-1, inp-5).Upon return, the distal end of the saf sheath was noted at approximately 44.3cm from the iabc distal tip (inp-6).The one-way valve was tethered to the short driveline tubing (inp-7).The iabc bladder was fully unwrapped (inp-8).A kink was noted to the iabc at approximately 63cm from the iabc distal tip (inp-9).Dried blood was noted on the exterior surfaces of the returned iabc; no obvious blood was noted within the helium pathway.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 according to quality system document.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 using the lt-l-015 in accordance with testing methods from manufacturing procedure.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 15 minutes.There were no alarms triggered.The bladder inflated and deflated completely with each beat.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 55.9cm, 58.3cm, 63.1cm and 76.0cm from the iabc distal tip.The guidewire was able to advance through the central lumen.Some blood was noted.The guidewire was front loaded through the iabc luer.Resistance was noted at approximately 9.2cm, 21.9cm, 27.1cm and 29.3cm from the iabc luer.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.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint was undetermined.No further action was required at this time.Teleflex will continue to monitor and trend for reports of this nature.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17383675
• Report Number: 3010532612-2023-00405
• Device Sequence Number: 6118138
• Product Code: DSP
• UDI-Device Identifier: 10801902161977
• UDI-Public: 10801902161977
• 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): 07/05/2023

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: 08/31/2023
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F21J0063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 67 KG