MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN038075
Medical Device Problem Codes	Leak/Splash (1354); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon would not completely inflate.As a result, the iab was removed and a second iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the balloon would not completely inflate.As a result, the iab was removed and a second iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The product was not returned for investigation.The customer provided videos for analysis.The videos were reviewed and show a fluoroscopy view of the patient and iab catheter.The videos did not show clear imaging of any damage to the iabc or any blood leak.The reported issue could not be confirmed based on review of the video.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint of iab "balloon leakage issue and the balloon was broken in body when doctor removes process, the blood reflux into the helium lumen" is not able to be confirmed.The product was not returned 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.If the product is returned at a later date, a full investigation of the sample will be completed.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that the balloon would not completely inflate.As a result, the iab was removed and a second iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint that the "blood reflux into the helium lumen" is confirmed.During the investigation, the iabc central lumen was noted damaged and found no longer attached to the iabc flex tip assembly.The damaged central lumen can result in blood entering the helium pathway.The iabc bladder was fully intact with no damage or abnormalities noted.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the damaged central lumen.The root cause of the complaint is undetermined.A non-conformance has been initiated to further investigate the issue.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17312380
• Report Number: 3010532612-2023-00382
• Device Sequence Number: 15269339
• Product Code: DSP
• UDI-Device Identifier: 00801902136695
• UDI-Public: 00801902136695
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K000729
• 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,Followup
• Report Date (Section B): 06/17/2023

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 Expiration Date: 07/31/2024
• Device Model Number: IPN038075
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F22H0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2023
• Supplement Date Received by Manufacturer: 08/04/2023; 11/17/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/07/2023; 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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