MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-06840-U
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The report states, "problems with shuttling of the helium was noticed immediately (balloon waveform) and troubleshooting was done for 30 minutes.Patient did not have an tortuous aorta nor was the patient obese.Initially the balloon did not unfurl completely and was expanded with a syringe in the usual manner.No kink was seen in the line when examined under fluoroscopy.The problem was sorted with readjustment of the catheter and sheath.On (b)(6) 2023 during a routine check it was noticed that the gas was not shuttling back (slow deflation) correctly and the catheter waveform was abnormal.At this point the console started alarming.We immediately removed the catheter from the patient.Errors seen were: gas loss alarm and gas gain alarm".No patient harm or injury.The patient status is reported as "stable".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.
Additional Manufacturer Narrative
Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4), the reported complaint that the "gas was not shuttling back (slow deflation)" is not able to be confirmed.The product was not returned for investigation.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.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.
Event or Problem Description
The report states, "problems with shuttling of the helium was noticed immediately (balloon waveform) and troubleshooting was done for 30 minutes.Patient did not have a tortuous aorta nor was the patient obese.Initially the balloon did not unfurl completely and was expanded with a syringe in the usual manner.No kink was seen in the line when examined under fluoroscopy.The problem was sorted with readjustment of the catheter and sheath.On (b)(6), 2023 during a routine check it was noticed that the gas was not shuttling back (slow deflation) correctly and the catheter waveform was abnormal.At this point the console started alarming.We immediately removed the catheter from the patient.Errors seen were: gas loss alarm and gas gain alarm".No patient harm or injury.The patient status is reported as "stable".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.

• Brand Name: ULTRAFLEX IAB: 7.5FR 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: 17503555
• Report Number: 3010532612-2023-00433
• Device Sequence Number: 20449834
• Product Code: DSP
• UDI-Device Identifier: 00801902136695
• UDI-Public: 00801902136695
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K000729
• 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): 07/24/2023

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: 05/31/2025
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F23F0015
• 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: 07/24/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Unknown
• Patient Weight: 90 KG