MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AUTOCAT 2; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN000302
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "on (b)(6) 2022, in the department of cardiovascular medicine, as the patient had an acute heart [myocardial] infarction with symptoms of cardiogenic shock, the physician prepared to insert a stent in the intra-aortic balloon, and in the process of use, the machine suddenly stopped working and alarmed".It was decided to "assess the patient's condition, immediately check the patient and the line for abnormalities, call the physician to examine the patient, monitor changes in vital signs, ask the patient if he/she has any symptoms of discomfort, pay attention to the patient's hemodynamics.Suspend the use of the machine and reported to the medical installation office at the same time.After restarting the pump, the machine can start normally".Patient condition is reported as "fine".Multiple attempts were made to the ask the customer clarifying information regarding the alarm that the pump gave, if there were any medical interventions, etc.The customer did not respond.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "on (b)(6) 2022, in the department of cardiovascular medicine, as the patient had an acute heart [myocardial] infarction with symptoms of cardiogenic shock, the physician prepared to insert a stent in the intra-aortic balloon, and in the process of use, the machine suddenly stopped working and alarmed".It was decided to "assess the patient's condition, immediately check the patient and the line for abnormalities, call the physician to examine the patient, monitor changes in vital signs, ask the patient if he/she has any symptoms of discomfort, pay attention to the patient's hemodynamics.Suspend the use of the machine and reported to the medical installation office at the same time.After restarting the pump, the machine can start normally".Patient condition is reported as "fine".Multiple attempts were made to the ask the customer clarifying information regarding the alarm that the pump gave, if there were any medical interventions, etc.The customer did not respond.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Additionally no recorder strip was returned for investigation.A device history record review was performed, and no relevant findings were identified.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.

• Brand Name: AUTOCAT 2
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15939217
• Report Number: 3010532612-2022-00554
• Device Sequence Number: 20434015
• Product Code: DSP
• UDI-Device Identifier: 30801902051722
• UDI-Public: 30801902051722
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/22/2022

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: IPN000302
• Device Catalogue Number: IAP-0400
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 50 YR
• Patient Sex: Unknown