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

Model Number	IPN915317
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The event occurred on (b)(6) 2022.It was reported that prior to insertion during calibration, "it did not fit and the calibration didn't happen".Upon further communication on (b)(6) 2022, the customer stated that the patient had expired.Multiple inquiries surrounding the event and death were made.On (b)(6) 2023, the customer stated "the device didn't cause or contribute to the patient's death.We will not answer other questions due to the protection of patient and doctor data".If teleflex receives additional information on this event, the complaint file will be updated.
Event or Problem Description
The event occurred on (b)(6) 2022.It was reported that prior to insertion during calibration, "it did not fit and the calibration didn't happen".Upon further communication on (b)(6) 2022, the customer stated that the patient had expired.Multiple inquiries surrounding the event and death were made.On (b)(6) 2023, the customer stated "the device didn't cause or contribute to the patient's death.We will not answer other questions due to the protection of patient and doctor data".If teleflex receives additional information on this event, the complaint file will be updated.
Additional Manufacturer Narrative
Qn# (b)(4).Upon investigation of the returned sample, it was found that the malfunction was not reportable; therefore, the initial mdr submitted on 04 jan 2023 should be retracted.Other remarks: n/a and 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: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16095818
• Report Number: 3010532612-2023-00005
• Device Sequence Number: 6651662
• Product Code: DSP
• UDI-Device Identifier: 10801902161892
• UDI-Public: 10801902161892
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K021462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2022

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: 10/31/2023
• Device Model Number: IPN915317
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F21L0039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• 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: Unknown