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

Catalog Number IAB-05840-LWS

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was placed on a patient and the fiber optic sensor (fos) signal was lost.They then transduced the arterial pressure (ap) signal from the central lumen.However, the signal from the central lumen appears much dampened despite several different flushes.The deflation timing also appears late.After switching to the alternate ap source (radial a-line), and with further discussion, it was determined that the deflation timing is correct.The pump is providing good support for the patient.The iab was continued to be used and was not replaced.No patient complications.No delay/interruption in therapy.No reported patient death or serious injury.There was no medical intervention required.

Event Description

It was reported that the intra-aortic balloon (iab) was placed on a patient and the fiber optic sensor (fos) signal was lost.They then transduced the arterial pressure (ap) signal from the central lumen.However, the signal from the central lumen appears much dampened despite several different flushes.The deflation timing also appears late.After switching to the alternate ap source (radial a-line), and with further discussion, it was determined that the deflation timing is correct.The pump is providing good support for the patient.The iab was continued to be used and was not replaced.No patient complications.No delay/interruption in therapy.No reported patient death or serious injury.There was no medical intervention required.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation.Therefore the reported complaint of iab central lumen occluded is not able to be confirmed.The root cause of the complaint could not be determined.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.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.No further action required at this time.

• 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: 7284977
• MDR Text Key: 100667570
• Report Number: 3010532612-2018-00023
• Device Sequence Number: 1
• Product Code: DSP
• 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: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F17E0056
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1