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

Model Number	IPN915319
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reported as "persistent helium loss 3 alarms, one high pressure alarm" as reported by a teleflex clinical support specialist, "[clinician] called regarding repeated helium loss 3 alarms.He endorsed team would restart pump and pump would issue alarm within 3-4 beats.I had [clinician] confirm there were no visible external kinks to driveline or catheter.He also denied any blood in the driveline.Recent xray at 0200 pst verified correct placement.We attempted to reposition patient without any changes to alarm frequency.Volume decreased to 35cc and 30cc without changes to alarm frequency.Pump could be heard alarming each time restart was attempted.Alarm then became "high pressure." additional xray was recommended.We discussed the possibility of the iab having a severe kink.Md opted to remove iab".They did not replace the iab.No patient harm or injury, patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The reported complaint for iab leak suspected is confirmed based on the customer photo provided with the complaint report.The product was not returned for investigation.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 helium loss/high pressure alarms.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
Reported as "persistent helium loss 3 alarms, one high pressure alarm" as reported by a teleflex clinical support specialist, "[clinician] called regarding repeated helium loss 3 alarms.He endorsed team would restart pump and pump would issue alarm within 3-4 beats.I had [clinician] confirm there were no visible external kinks to driveline or catheter.He also denied any blood in the driveline.Recent xray at 0200 pst verified correct placement.We attempted to reposition patient without any changes to alarm frequency.Volume decreased to 35cc and 30cc without changes to alarm frequency.Pump could be heard alarming each time restart was attempted.Alarm then became "high pressure." additional xray was recommended.We discussed the possibility of the iab having a severe kink.Md opted to remove iab".They did not replace the iab.No patient harm or injury, patient status is reported as "fine".

• Brand Name: FIBEROPTIX 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16336846
• Report Number: 3010532612-2023-00091
• Device Sequence Number: 6420180
• Product Code: DSP
• UDI-Device Identifier: 10801902167733
• UDI-Public: 10801902167733
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K021462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2023

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: IPN915319
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F22H0023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2022
• 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