MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-06830-U
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the "iab tubing connection was found to be leaking after moving patient to or table and subsequently lost pressure waveform.It was tightened best as possible and taped with a tegaderm.The remedy was to remove the tubing with the stopcock all together and direct wet to wet connection.We flushed the line and re-zeroed, and the pressure waveform returned.This was after the patient was in sicu post-op.Iab was later removed." no patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).The reported complaint of "hub on extension connector broke" was confirmed upon investigation of the returned sample.The customer returned a 30cc 7.5fr ultraflex iab catheter without the original packaging for investigation.Upon return, the short ap extension tubing was noted damaged; the damage consisted of the male luer end being cracked/broken and separated from the short ap extension tubing.The broken ap tubing can result in a leak at the iabc luer end.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 broken luer of the ap tubing.The root cause of the complaint is undetermined.A potential cause is user related, where the ap connection is overtightened.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that the "iab tubing connection was found to be leaking after moving patient to operating room table and subsequently lost pressure waveform.It was tightened best as possible and taped with a tegaderm.The remedy was to remove the tubing with the stopcock all together and direct wet to wet connection.We flushed the line and re-zeroed, and the pressure waveform returned.This was after the patient was in sicu post-op.Iab was later removed." no patient harm or injury.The patient status is reported as "fine".

• Brand Name: ULTRA 8 IAB: 8FR 30CC
• 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: 17541064
• Report Number: 3010532612-2023-00447
• Device Sequence Number: 12650437
• Product Code: DSP
• UDI-Device Identifier: 00801902010742
• UDI-Public: 00801902010742
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 07/26/2023

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: 11/30/2024
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F22M0019
• 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: 07/26/2023
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2022
• 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: Unknown