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

Catalog Number	IAP-0500I
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported " the iabp doesn't work, low battery alarm".Additionally it is stated that this issue happened prior to use.No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The reported complaint of "iabp doesn't work, low battery alarm" 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.Iabp users and servicers must follow the operating instructions manual for recommendations on usage, charging, maintenance and storage of the batteries.If battery maintenance is not performed per the iabp operating instructions manual, the battery may not provide the expected minimum run time of operating power.
Event or Problem Description
It was reported " the iabp doesn't work, low battery alarm".Additionally it is stated that this issue happened prior to use.No patient involvement reported.

• Brand Name: AUTOCAT2 WAVE ITALIAN
• 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: 19187836
• Report Number: 3010532612-2024-00322
• Device Sequence Number: 15200954
• Product Code: DSP
• UDI-Device Identifier: 30801902092190
• UDI-Public: 30801902092190
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 04/08/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: IAP-0500I
• 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: 04/08/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/28/2024
• 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 Sex: Unknown