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

Model Number IPN039787

Device Problems Failure to Zero (1683); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is reportable due to the decision to exchange the iab catheter to continue therapy, which can result in delay in patient therapy and harms.However, 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.

Event Description

It was reported that during insertion of the intra-aortic balloon (iab) the fos did not connection.As a result, another iab was used for treatment.There was a delay in treatment.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn#(b)(4).No part was returned to teleflex chelmsford for investigation.The reported complaint that the "fos did not connect" is not able to be confirmed.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.The "brand name" had the incorrect information.Once this was noticed the correct information was immediately placed.Other remarks: this complaint is reportable due to the decision to exchange the iab catheter to continue therapy, which can result in delay in patient therapy and harms.However, 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.

Event Description

It was reported that during insertion of the intra-aortic balloon (iab) the fos did not connection.As a result, another iab was used for treatment.There was a delay in treatment.There was no report of patient complications, serious injury or death.

Event Description

It was reported that during insertion of the intra-aortic balloon (iab) the fos did not connection.As a result, another iab was used for treatment.There was a delay in treatment.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn# (b)(4).Teleflex received the device for investigation.The reported complaint of iab fos would not zero is confirmed.The fos fiber was broken and therefore the light path could not be established between the sensor and the pump.The root cause of the broken fiber 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 complaint is reportable due to the decision to exchange the iab catheter to continue therapy, which can result in delay in patient therapy and harms.However, 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.Corrected data: a sample was returned for investigation.Under section d9 the field has been changed from "no' to "yes".

• 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: 10250010
• MDR Text Key: 198094929
• Report Number: 3010532612-2020-00187
• 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,Followup
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: IPN039787
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F20C0052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1