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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that while in use on a patient in the or during a cabg surgery, "the device was leaking and the operators attempted to tighten the connection and the result was a complete break on the hub of the tubing.Remedy was press the connection together as tight as possible and they taped it together to get them through the case.The patient lost about 300cc's of blood as the connection was under the sterile drape and the leak was not detected until they heard 'dripping' onto the floor from under the sterile drape.The patient had to be transfused as a result.".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Customer provided 5 pictures of the affected device.The pictures were reviewed and show the broken ap extension tubing related to mdr 3010532612-2023-00447.A device history record review was performed, and no relevant findings were identified.The reported complaint of "hub on extension connector broke" is not able to be confirmed.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that while in use on a patient in the or during a cabg surgery, "the device was leaking and the operators attempted to tighten the connection and the result was a complete break on the hub of the tubing.Remedy was press the connection together as tight as possible and they taped it together to get them through the case.The patient lost about 300cc's of blood as the connection was under the sterile drape and the leak was not detected until they heard 'dripping' onto the floor from under the sterile drape.The patient had to be transfused as a result.".

• 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17540894
• Report Number: 3010532612-2023-00445
• Device Sequence Number: 15058442
• 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: 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?: Yes
• 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?: Yes
• 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: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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