MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC FIBEROPTIX ULTRA 8 IAB: 8FR 50CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN916138
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4) n/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that the fos sensor tip was recessed.As a result, the iab was removed and a 2nd iab was inserted.Per the customer it is unknown if the same or a different insertion site was used.No patient harm or injury.The patient status is reported as "fine".
Event or Problem Description
It was reported that the fos sensor tip was recessed.As a result, the iab was removed and a 2nd iab was inserted.Per the customer it is unknown if the same or a different insertion site was used.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint for iab "recessed fos and didn't work" was not able to be confirmed as the product was not returned for investigation.A device history record (dhr) review was conducted for the lot numbers based on shipping history and no relevant findings were identified.All devices passed manufacturing specifications prior to release.The root cause of the complaint was undetermined, and no further action was required at the time of this report.The reported complaint will be monitored for any developing trends.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 50CC
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17215896
• Report Number: 3010532612-2023-00346
• Device Sequence Number: 16899590
• Product Code: DSP
• UDI-Device Identifier: 10801902167726
• UDI-Public: 10801902167726
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 06/01/2023

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: IPN916138
• Device Catalogue Number: IAB-05850-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: 06/01/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 07/24/2023
• 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
• Patient Sex: Male