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

Model Number	IPN039791
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reported as "blood noted in helium tubing".As reported by the clinical support specialist: "nurse noted blood in the helium tubing when she was doing her assessment.The pump is pumping and not alarming.She called the hot-line.I had her stop pumping, clamp the tubing, and disconnect the catheter from the pump.Next she contacted the physician to come and remove the catheter.This is a female patient with a 30 cc fiberoptic iab.The catheter was placed yesterday at about 1 pm while the patient was in the cath lab.The patient had a dissected lad and mitral valve regurg.They are trying to decide if the patient will go for a high risk ptci or cabg surgery.The patient is stable".Per the customer it is unknown if a second catheter was inserted.No report of patient harm or injury.Patient status reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Reported as "blood noted in helium tubing".As reported by the clinical support specialist: "nurse noted blood in the helium tubing when she was doing her assessment.The pump is pumping and not alarming.She called the hot-line.I had her stop pumping, clamp the tubing, and disconnect the catheter from the pump.Next she contacted the physician to come and remove the catheter.This is a female patient with a 30 cc fiberoptic iab.The catheter was placed yesterday at about 1 pm while the patient was in the cath lab.The patient had a dissected lad and mitral valve regurg.They are trying to decide if the patient will go for a high risk ptci or cabg surgery.The patient is stable".Per the customer it is unknown if a second catheter was inserted.No report of patient harm or injury.Patient status reported as "fine".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16157444
• Report Number: 3010532612-2023-00029
• Device Sequence Number: 7515638
• Product Code: DSP
• UDI-Device Identifier: 10801902145700
• UDI-Public: 10801902145700
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/10/2023

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 Expiration Date: 10/31/2023
• Device Model Number: IPN039791
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F21L0005
• 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: 01/10/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• 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: Female