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

Model Number	IPN915322
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn # (b)(4).
Event or Problem Description
It was reported that "after 3 minutes of use, the machine frequently alarms 'helium leakage'.Adjusting the equipment and catheter cannot solve the problem.After replacing the catheter, the problem was resolved.In vitro experiments confirmed that the tip of the catheter was damaged and helium leakage occurred.".The 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 3 minutes of use, the machine frequently alarms 'helium leakage'.Adjusting the equipment and catheter cannot solve the problem.After replacing the catheter, the problem was resolved.In vitro experiments confirmed that the tip of the catheter was damaged and helium leakage occurred.".The 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint that the "machine frequently alarms helium leakage" was not confirmed.The customer returned a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) with the original packaging box that matches the serial number on the returned sample (inp-2, inp-4) for investigation.The sample was returned in a cardboard box and was loosely packaged within the original packaging box (inp-1, inp-5).Returned with the sample were supplied kit components including 0.025in guidewire and 40cc inflation driveline tubing; no damage or abnormalities were noted to the returned components (inp-7).Upon return, the peel away sheath was noted on the returned sample (inp-6).The one-way valve was tethered to the short driveline tubing (inp-8).The bladder was fully unwrapped (inp-9).Two bends to the iabc were noted at approximately 34.5cm and 72.3cm from the iabc distal tip (inp-10, inp-11).Dried blood was noted on the exterior surfaces of the returned iabc.No blood was noted within the helium pathway.Further inspection of the iabc distal tip and central lumen/flex-tip assembly was performed.No visual damage or abnormalities were noted.The bladder thickness was measured at six points with measurements ranging from 0.0058in-0.0065in and was within specification of process document.As part of functional inspection, the one-way valve was tested and passed.A vacuum was pulled on the one-way valve, and it held for at least 1 m inute 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 the returned 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.Resistance was noted at approximately 34.2cm and 72.3cm from the iabc distal tip, which are the locations of the previously noted bends.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.Resistance was noted at approximately 9.4cm from the iabc luer, which was the location of the previously noted bend.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 root cause of the complaint was undetermined.No further action required at the time of the report.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17152142
• Report Number: 3010532612-2023-00333
• Device Sequence Number: 20326577
• Product Code: DSP
• UDI-Device Identifier: 10801902161946
• UDI-Public: 10801902161946
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/29/2023

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: 05/31/2024
• Device Model Number: IPN915322
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F22F0043
• 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: 05/29/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown