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

Catalog Number	IAP-0500J
Medical Device Problem Codes	Connection Problem (2900); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported " it was reported that a refill error occurred and it was impossible to input external ecg during use ac2.Therefore, the ac2 was replaced to another pump of not-teleflex".The patient's current condition is reported as "fine".
Event or Problem Description
It was reported " it was reported that a refill error occurred and it was impossible to input external ecg during use ac2.Therefore, the ac2 was replaced to another pump of not-teleflex".The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint of "impossible to input external ecg" is not able to be confirmed.No iabp 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.

• Brand Name: ARROW AUTOCAT2 WAVE JAPANESE
• 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: 19226108
• Report Number: 3010532612-2024-00298
• Device Sequence Number: 20767042
• Product Code: DSP
• UDI-Device Identifier: 00801902043429
• UDI-Public: 00801902043429
• 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: Foreign,User Facility,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-0500J
• 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 REPORTED; NONE REPORTED
• Patient Sex: Unknown