MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AUTOCAT2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN000320
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that system error 7 and helium loss alarms were detected during preventive maintenance.No patient involvement.
Additional Manufacturer Narrative
(b)(4).The reported complaint of "helium loss alarm" was confirmed upon investigation of the returned sample.The customer returned an ac2 pump assembly without its original pcs assembly (part number 77-3200-001, s/n (b)(6) for investigation.The sample was returned in a brown cardboard box with protective shipping packaging (inp-1 through inp-4).Visual inspection of the pump assembly was performed (inp-4 through inp-12), and dried blood was noted inside the bellow port (inp-11, inp-12).Functional testing could not be performed due to the blood contamination.Note: blood can only enter the iabp from an iab that develops a leak.The ifu states: "intra-aortic balloon membrane perforation may occur during iabp therapy.The occurrence and severity of the iab perforation is unpredictable and may be due to patient physiology, accidental contact with a sharp instrument or by contact with calcified plaque resulting in membrane surface abrasion and eventual perforation.Large perforations are rare.Small perforations can result in asymptomatic release of gas.Perforation can cause blood to appear in the balloon catheter and driveline tubing." 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 dried blood buildup inside the pump assembly.The root cause of the complaint was undetermined.No further action required at this time.Teleflex will continue to monitor and trend for complaints of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that system error 7 and helium loss alarms were detected during preventive maintenance.No patient involvement.

• Brand Name: AUTOCAT2 WAVE
• 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: 18439868
• Report Number: 3010532612-2024-00016
• Device Sequence Number: 7780648
• Product Code: DSP
• UDI-Device Identifier: 30801902051715
• UDI-Public: 30801902051715
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K060309
• 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): 12/12/2023

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 Model Number: IPN000320
• Device Catalogue Number: IAP-0500I
• Device Lot Number: N/A
• 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: 12/12/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown