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

Catalog Number IAB-05840-LWS

Device Problems No Device Output (1435); Unable to Obtain Readings (1516); Failure to Zero (1683)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was connected to the intra-aortic balloon pump (iabp) and the fiberoptic did not register.The iab was connected on two separate iabp with no change.As a result, a new iab was opened and successfully inserted into patient.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.

Event Description

It was reported that the intra-aortic balloon (iab) was connected to the intra-aortic balloon pump (iabp) and the fiberoptic did not register.The iab was connected on two separate iabp with no change.As a result, a new iab was opened and successfully inserted into patient.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).No iab parts was returned to teleflex chelmsford for investigation.The reported complaint of iab fos would not zero is not able to be confirmed.The product was not returned for investigation.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 revived risk.This will be monitored for any developing trends.Other remarks: this report would not be likely to cause or contribute to a death or serious injury.A fiber optic sensor (fos) not connecting cannot in itself cause or contribute to a patient death or serious injury.The fos is a portion of the catheter that monitors the patient's arterial pressure.When the fiber optic pressure signal is not available, the intra-aortic balloon (iab) is still able to be used since an arterial pressure signal is available through the central lumen.Iab therapy continues to the patient uninterrupted.This system does not require the clinician to remove the iab in the event that the fos is lost.It was reported that there was no patient injury or consequence.Although, a delay while another iab is obtained this is unlikely, to cause or contribute to patient injury.

• 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: 9144836
• MDR Text Key: 160856131
• Report Number: 3010532612-2019-00352
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

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: 02/28/2020
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F18C0044
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 10/25/2019
• Supplement Dates FDA Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1