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

Model Number	IPN915325
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
Reported as "iab removed-possible abrasion"."[clinician] called the hotline for assistance with persistent helium loss 2 alarms, they have confirmed placement via x-ray, changed the helium tank, there are no noted connect issues or leaks, no blood noted in the tubing.The patient is in sinus rhythm, autopilot mode, ecg trigger.Alarm history noted only helium loss 2 alarm occurring approximately every 3 minutes.Requested alarm strip and it shows no noted kinking, partial obstruction, or large loss of baseline.Rn reported that a 9f sheath 'not from the iab kit' was used for [right femoral] insertion earlier in the day.She is unsure why this sheath was used.I explained to the [clinician]that based on the bpw, this appears to be a leak.We discussed and then performed a leak test (facetime unavailable).Helium loss 3 alarms with leak test at pump, pump exchanged, low confidence that leak test was performed accurately.I explained a leak in the pump is rare but that exchanging the pump would ensure the issue was not pump related, the helium loss alarms continued on the second pump.I explained to the [clinician] that this confirms the issue is catheter related.I discussed that although no blood is present, an abrasion could allow blood to accumulate in the iab and cause catheter entrapment.We also discussed the difference in helium delivery and gas alarms on this pump compared to their previous pump.I recommended she discuss catheter removal and or replacement with the md.During this discussion she did also comment that the patient was noted to have sev ere calcification during the insertion.Iab was removed without difficulty and a second iab was inserted without issue." no patient harm or injury, patient status is reported as "fine".Second iab was inserted at the same insertion site.
Event or Problem Description
Reported as "iab removed-possible abrasion"."[clinician] called the hotline for assistance with persistent helium loss 2 alarms, they have confirmed placement via x-ray, changed the helium tank, there are no noted connect issues or leaks, no blood noted in the tubing.The patient is in sinus rhythm, autopilot mode, ecg trigger.Alarm history noted only helium loss 2 alarm occurring approximately every 3 minutes.Requested alarm strip and it shows no noted kinking, partial obstruction, or large loss of baseline.Rn reported that a 9f sheath 'not from the iab kit' was used for [right femoral] insertion earlier in the day.She is unsure why this sheath was used.I explained to the [clinician]that based on the bpw, this appears to be a leak.We discussed and then performed a leak test (facetime unavailable).Helium loss 3 alarms with leak test at pump, pump exchanged, low confidence that leak test was performed accurately.I explained a leak in the pump is rare but that exchanging the pump would ensure the issue was not pump related, the helium loss alarms continued on the second pump.I explained to the [clinician] that this confirms the issue is catheter related.I discussed that although no blood is present, an abrasion could allow blood to accumulate in the iab and cause catheter entrapment.We also discussed the difference in helium delivery and gas alarms on this pump compared to their previous pump.I recommended she discuss catheter removal and or replacement with the md.During this discussion she did also comment that the patient was noted to have sev ere calcification during the insertion.Iab was removed without difficulty and a second iab was inserted without issue." no patient harm or injury, patient status is reported as "fine".Second iab was inserted at the same insertion site.
Additional Manufacturer Narrative
(b)(4).The reported complaint for iab helium loss alarm is confirmed based on the customer photo provided with the complaint report.The product was not returned for investigation.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 helium loss alarm.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.If the product is returned at a later date, a full investigation of the sample will be completed.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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16313244
• Report Number: 3010532612-2023-00088
• Device Sequence Number: 6326928
• Product Code: DSP
• UDI-Device Identifier: 10801902161977
• UDI-Public: 10801902161977
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K981660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2023

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: 09/30/2024
• Device Model Number: IPN915325
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F22K0046
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2022
• 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 Sex: Male