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

Model Number IPN039792

Device Problems Fluid/Blood Leak (1250); Failure to Zero (1683)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the fos was not detected after the intra-aortic balloon (iab) was inserted.The fos did not zero.As a result, the iab was replaced.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).The product was not returned for investigation.The reported complaint of iab fos would not zero is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.Corrected data: medical device problem code should be 1683 and not 1250.The code has been updated.

Event Description

It was reported that the fos was not detected after the intra-aortic balloon (iab) was inserted.The fos did not zero.As a result, the iab was replaced.There was no report of patient complications, serious injury or death.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11930332
• MDR Text Key: 254059087
• Report Number: 3010532612-2021-00163
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: 00801902007247
• Combination Product (y/n): N
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: IPN039792
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F21C0028
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1