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

Catalog Number	IAP-0400
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "in the process of using iabp, there were 2 times when the instrument suddenly stopped with a black screen without any alarm.Suddenly black screen shutdown under the prompt, about 2 minutes after restarting can run normally.Because of the repeated black screen failure of the device, the patient has been replaced with a new device for treatment." the iabp was removed and replaced.No delay or interruption to therapy.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The reported complaint of "instrument suddenly stopped with a black screen" is not able to be confirmed.The product was not returned for investigation.According to additional information received, the issue was not able to be duplicated.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.
Event or Problem Description
It was reported "in the process of using iabp, there were 2 times when the instrument suddenly stopped with a black screen without any alarm.Suddenly black screen shutdown under the prompt, about 2 minutes after restarting can run normally.Because of the repeated black screen failure of the device, the patient has been replaced with a new device for treatment." the iabp was removed and replaced.No delay or interruption to therapy.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19226103
• Report Number: 3010532612-2024-00292
• Device Sequence Number: 12696354
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2024

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 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: 03/26/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/15/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPROTED; NONE REPROTED
• Patient Sex: Unknown