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

Model Number	IPN000325
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that soon after placement of the intra-aortic balloon catheter (iabc), premature ventricular contraction (pvc) occurred continuously and helium loss alarm occurred frequently.Then as the patient's arrhythmia receded, the alarms stopped.A short time later, the patient's aortic pressure began to reduce and the helium loss alarms occurred frequently, again.The hospital staff rebooted the intra-aortic balloon pump (iabp) and checked all connections, but the alarms persists.As the patient's condition became worse, the staff activated the iabp by internal trigger mode, which stopped the alarm.There was no report of patient injury or consequence.Patient outcome reported as fine.
Event or Problem Description
It was reported that soon after placement of the intra-aortic balloon catheter (iabc), premature ventricular contraction (pvc) occurred continuously and helium loss alarm occurred frequently.Then as the patient's arrhythmia receded, the alarms stopped.A short time later, the patient's aortic pressure began to reduce and the helium loss alarms occurred frequently, again.The hospital staff rebooted the intra-aortic balloon pump (iabp) and checked all connections, but the alarms persists.As the patient's condition became worse, the staff activated the iabp by internal trigger mode, which stopped the alarm.There was no report of patient injury or consequence.Patient outcome reported as fine.
Additional Manufacturer Narrative
(b)(4).Teleflex did not receive the device for investigation.The reported complaint of helium loss 3 alarm is confirmed based on the picture of the recorder strip provided in the complaint.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.This will be monitored for any developing trends.An in-service has been requested to reiterate the instructions for use (ifu) to the customer.

• Brand Name: AUTOCAT2 WAVE JAPANESE
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9729656
• Report Number: 3010532612-2020-00048
• Device Sequence Number: 11297676
• Product Code: DSP
• UDI-Device Identifier: 30801902043420
• UDI-Public: 30801902043420
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2020

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: IPN000325
• Device Catalogue Number: IAP-0500J
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1