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

Model Number	IPN915319
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Reported as "balloon rupture".As reported by the clinical support specialist: "received a call from biomed about possible blood back in the ac3 from a balloon rupture on (b)(6) 2023.I was able to get some further information from the clinical resource in the unit about the situation.The patient had an axillary insertion of the balloon on (b)(6) 2022.On early morning on (b)(6) 2023 the staff found blood in the helium tubing.The physician was notified.The patient was taken to the or later that morning to remove and replace the iab.There were no complications with the removal or the patient.A second fiberoptic iab was placed axillary.The patient is stable." no patient injury or consequence.The patient condition is reported as "fine".
Event or Problem Description
Reported as "balloon rupture".As reported by the clinical support specialist: "received a call from biomed about possible blood back in the ac3 from a balloon rupture on (b)(6)2023.I was able to get some further information from the clinical resource in the unit about the situation.The patient had an axillary insertion of the balloon on (b)(6) 2022.On early morning (b)(6) 2023 the staff found blood in the helium tubing.The physician was notified.The patient was taken to the or later that morning to remove and replace the iab.There were no complications with the removal or the patient.A second fiberoptic iab was placed axillary.The patient is stable." no patient injury or consequence.The patient condition is 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.

• 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: 16184254
• Report Number: 3010532612-2023-00033
• Device Sequence Number: 16720299
• Product Code: DSP
• UDI-Device Identifier: 10801902167733
• UDI-Public: 10801902167733
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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 Model Number: IPN915319
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 01/17/2023
• Supplement Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Male