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

Model Number 00801902136718

Device Problem Failure to Zero (1683)

Patient Problem Insufficient Information (4580)

Event Date 05/05/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the fos was unable to be zeroed and the signal was weak.As a result, a new catheter was inserted.At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

Manufacturer Narrative

Qn#(b)(4).The reported complaint for iab "weak fos signal and couldn't zero fos" is not able to be confirmed.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.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.

Event Description

It was reported that the fos was unable to be zeroed and the signal was weak.As a result, a new catheter was inserted.At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17012300
• MDR Text Key: 316517455
• Report Number: 3010532612-2023-00296
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00801902136718
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F23A0018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male