MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN000255
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the clinical support specialist (css) that the staff received possible helium loss alarms.There was a drop to the baseline of the bpw when it alarms; however, the bpw otherwise looked normal.There was no blood in the gas tubing and all the connections were well secured.The iab did failed the leak test.As a result, the iab was removed.There was no report of patient complications, serious injury or death.
Additional Manufacturer Narrative
(b)(4).There is an investigation ongoing into this reported complaint.A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.
Additional Manufacturer Narrative
(b)(4).The product was not returned for investigation.The reported complaint of iab leak suspected is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.The root cause of the complaint is undetermined.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.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.
Event or Problem Description
It was reported by the clinical support specialist (css) that the staff received possible helium loss alarms.There was a drop to the baseline of the bpw when it alarms; however, the bpw otherwise looked normal.There was no blood in the gas tubing and all the connections were well secured.The iab did failed the leak test.As a result, the iab was removed.There was no report of patient complications, serious injury or death.

• Brand Name: ULTRA 8 IAB: 8FR 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: kaylia pen ; 16 elizabeth drive; chelmsford, MA 01824
• MDR Report Key: 14336461
• Report Number: 3010532612-2022-00156
• Device Sequence Number: 5221466
• Product Code: DSP
• UDI-Device Identifier: 00801902010759
• UDI-Public: 00801902010759
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K000729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2022

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: 09/30/2023
• Device Model Number: IPN000255
• Device Catalogue Number: IAB-05840-U
• Device Lot Number: 18F21K0050
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2021
• 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: Male