MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AC3 IABP NA/AJLA; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAP-0601
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while in use on a patient, "the intra-aortic balloon pump gas was used too quickly, affecting the normal use of the equipment".No patient harm or injury.The patient status is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4), the reported complaint of helium dissipate too quickly was not able to be confirmed as no iabp part was returned for investigation.According to the event details, the issue was resolved after reseating the helium tank sealing washer.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.The root cause of the complaint was undetermined.No further action was required at this time.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that while in use on a patient, "the intra-aortic balloon pump gas was used too quickly, affecting the normal use of the equipment".No patient harm or injury.The patient status is reported as "fine".As per the additional information, the patient had an underlying medical condition of coronary heart disease.

• Brand Name: AC3 IABP NA/AJLA
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17398750
• Report Number: 3010532612-2023-00422
• Device Sequence Number: 20313919
• Product Code: DSP
• UDI-Device Identifier: 10801902172096
• UDI-Public: 10801902172096
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 07/10/2023

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-0601
• 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: 07/10/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown