MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-05840-U
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported " iab rupture".Additionally it was reported that the user noted "blood specks" in the driveline.The user also noted a single helium loss alarm and purge failure alarms noted as having occured right after insertion.Therapy was stopped and iab discontinued.Patient was revalscularized in the or via planned cabg.No patient injury or consequence reported.Patient's current condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported " iab rupture".Additionally it was reported that the user noted "blood specks" in the driveline.The user also noted a single helium loss alarm and purge failure alarms noted as having occured right after insertion.Therapy was stopped and iab discontinued.Patient was revalscularized in the or via planned cabg.No patient injury or consequence reported.Patient's current condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint for iab blood in helium pathway was confirmed upon investigation of the returned sample.Visual inspection revealed a bend to the iabc at approximately 62.3cm from the iabc distal tip.The iabc central lumen within the flex-tip assembly area was noted damaged and the wire round/polyimide (part of the flex tip assembly) was noted partially broken at approximately 6.5cm from the iabc distal tip, which caused blood to enter the helium pathway.Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was noted within the helium pathway.An attempt to aspirate and flush the iabc central lumen was performed as part of functional inspection using a 60cc lab-inventory syringe and was unsuccessful as the water was unable to be consistently pulled into the syringe upon aspiration.The attempt to flush resulted in bladder inflation.The results are consistent with the previously noted damaged central lumen.The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was immediately detected from the iabc distal tip and iabc luer end.The leak from the iabc distal tip and iabc luer end are consistent with the previously confirmed damaged central lumen.The iabc was leak tested again with the iabc distal tip and luer end blocked off; no other leaks were detected.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 damaged central lumen.The root cause of the complaint was undetermined.Further investigation has been initiated under teleflex quality systems to evaluate this issue.

• Brand Name: ARROW ULTRA 8 IAB: 8FR 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: 18744048
• Report Number: 3010532612-2024-00134
• Device Sequence Number: 15264794
• Product Code: DSP
• UDI-Device Identifier: 00801902010759
• UDI-Public: 00801902010759
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K000729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2024

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
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: IAB-05840-U
• Device Lot Number: 18F23K0063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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: AC3; AC3
• Patient Sex: Male