MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN915317
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was received via transfer from an outside facility, brockton, there were rusty colored flecks of blood noted in the gas line and the flecks are on the inside of the tubing but there were no alarms.No alarm strips were provided.The iab was removed and replaced in the same site.There were no complications with removal or reinsertion.Patient is currently stable on the pump.
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
It was reported that the patient was received via transfer from an outside facility, (b)(6), there were rusty colored flecks of blood noted in the gas line and the flecks are on the inside of the tubing but there were no alarms.No alarm strips were provided.The iab was removed and replaced in the same site.There were no complications with removal or reinsertion.Patient is currently stable on the pump.
Additional Manufacturer Narrative
Qn#(b)(4).The product was not returned for investigation.A device history record review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The risk of the reported event is acceptable.The reported issue cannot be confirmed because the sample was not returned for investigation to teleflex chelmsford.The complaint will be monitored for any developing trends.The reported complaint for iab blood in helium pathway is not able to be confirmed.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.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15673590
• Report Number: 3010532612-2022-00447
• Device Sequence Number: 17747660
• Product Code: DSP
• UDI-Device Identifier: 10801902161892
• UDI-Public: 10801902161892
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K021462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 10/09/2022

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: 07/31/2022
• Device Model Number: IPN915317
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F20H0012
• 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: 10/09/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2020
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown