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

Catalog Number	IAP-0500
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported " the patient was admitted to our department because of acute myocardial infarction and cardiogenic shock, and he underwent ecmo and iabp cardiac assistance, and on 04-15 iabp was suddenly shut down, so he was forced to get off the plane, and the patient's circulation fluctuated, and vasoactive drugs were added to maintain him".Additional information states "the device was working normally when it suddenly stopped working and the clinician observed the patient's condition and chose to unplug the iabp, still retaining the ecmo.The patient's condition was stabilized, the ecmo was subsequently withdrawn, and he has recovered and been discharged from the hospital".The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn #(b)(4).The reported complaint of the pump shut down unintentionally is not able to be confirmed.No part was returned to teleflex chelmsford for investigation.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, "the patient was admitted to our department because of acute myocardial infarction and cardiogenic shock, and he underwent ecmo and iabp cardiac assistance, and on 04-15 iabp was suddenly shut down, so he was forced to get off the plane, and the patient's circulation fluctuated, and vasoactive drugs were added to maintain him".Additional information states "the device was working normally when it suddenly stopped working and the clinician observed the patient's condition and chose to unplug the iabp, still retaining the ecmo.The patient's condition was stabilized, the ecmo was subsequently withdrawn, and he has recovered and been discharged from the hospital".The patient's current condition is reported as "fine".

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19360371
• Report Number: 3010532612-2024-00369
• Device Sequence Number: 17086374
• Product Code: DSP
• UDI-Device Identifier: 30801902051715
• UDI-Public: 30801902051715
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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-0500
• 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: 04/23/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 06/13/2024
• 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
• Patient Age: 69 YR
• Patient Sex: Male