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

Model Number	IPN915322
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the day after the catheter was inserted, the pump alarmed, and the nurse found the that the connection between the sheath hub and the suture wing was loose.The catheter was removed, and a second catheter was inserted at the same insertion site.No report of patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).No serial number was reported.The serial number on the returned sample is el20848.The lot number (18f22e0048) recorded on the complaint report matches the lot number for the returned sample.Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.Upon return, the teflon sheath hub was not connected to the hemostasis cuff.A portion of the bladder was noted covered by the teflon sheath; there was no evidence noted that indicates the user attempted to withdraw the iabc through the teflon sheath.The distal end of the teflon sheath was noted at approximately 19.3cm from the iabc distal tip; liquid blood/fluid was noted within the sheath sidearm.The one-way valve was tethered to the short driveline tubing.The supplied short arterial pressure tubing was noted connected to the iabc luer end; clear fluid was noted within the ap tubing.The exposed portion of the bladder was fully unwrapped.The hemostasis cuff appeared typical; the cuff connection and its components were inspected, with no damage or abnormality noted to the parts.The teflon sheath hub appeared typical; no damage or abnormalities were noted.Dried blood was noted on the exterior surfaces of the returned iabc; no blood was noted within the helium pathway.Dried yellow media was noted on the hemostasis cuff, cathguard and iabc bifurcate.No visual damage or abnormalities were noted to the returned sample.The bladder thickness was measured at six points with measurements ranging from 0.0062in-0.0067in.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 one-way valve was connected to the iabc short driveline tubing, and a vacuum was pulled on the returned iabc.While maintaining the vacuum, the sheath was moved towards iabc bifurcate without any difficulty.The bladder appeared typical, and no apparent damage was noted.The hemostasis cuff was re-connected and disconnected multiple times with the teflon sheath hub, without difficulty; the connection appeared secure, no loose connection was noted.The iabc was leak tested.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 100mmhg 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.The balloon pressure waveform (bpw) was normal.No loose connection was noted between the hemostasis cuff and teflon sheath during pump testing.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.Some blood noted on the guidewire.The guidewire was front loaded through the iabc luer.No resistance was noted; the guidewire was able to advance through the central lumen.Some blood noted on the guidewire.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 risk is acceptable.The returned device passed visual and functional testing.The reported complaint for catheter damaged is not confirmed.During visual inspection, no damage or abnormalities were noted to the iabc hemostasis cuff and teflon sheath.There was no connection problem iden tified during the investigation and no leaks were noted.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 unde termined.No further action required at this time.
Event or Problem Description
It was reported that the day after the catheter was inserted, the pump alarmed, and the nurse found the that the connection between the sheath hub and the suture wing was loose.The catheter was removed, and a second catheter was inserted at the same insertion site.No report of patient harm or injury.The patient status is reported as "fine.".

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16150854
• Report Number: 3010532612-2023-00025
• Device Sequence Number: 7469991
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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: IPN915322
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F22E0048
• 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: 01/06/2023
• Supplement Date Received by Manufacturer: 02/25/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• 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: Female