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

Catalog Number IAB-05840-LWS

Device Problem Gas/Air Leak (2946)

Patient Problem Injury (2348)

Event Date 03/05/2019

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).For event details related to the same patient see mdr #3010532612-2019-00075 and tc #(b)(4).

Event Description

It was reported that intra-aortic balloon (iab) was placed in the patient.The patient was transferred to an outside hospital when persistent helium loss alarms began.There was no was evidence of blood in the tubing and the patient is not moving.It was noted that the white ring on the helium drive line tubing would not stay in place.As a result, the iab was exchanged to the opposite site.The patient is meeting the goals of therapy.There was a report of delay in therapy.There was no report of patient death.

Event Description

It was reported that intra-aortic balloon (iab) was placed in the patient.The patient was transferred to an outside hospital when persistent helium loss alarms began.There was no was evidence of blood in the tubing and the patient is not moving.It was noted that the white ring on the helium drive line tubing would not stay in place.As a result, the iab was exchanged to the opposite site.The patient is meeting the goals of therapy.There was a report of delay in therapy.There was no report of patient death.

Manufacturer Narrative

(b)(4).For event details related to the same patient see mdr #3010532612-2019-00075 and tc #1900066880.Teleflex received the device for investigation.The reported complaint of helium loss alarm is confirmed based on the customer pictures provided with the complaint report.During leak testing, a small external leak was identified on the mating connection between the iab short driveline tubing to inflation driveline tubing.No other leaks were detected.It is possible that the small external leak could cause or contribute to a helium loss alarm.The root cause of the helium loss alarm is undetermined, but a potential cause is an external leak from the driveline connection.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 risks.This will be monitored for any developing trends.A non-conformance has been initiated to further investigate the cause.

• 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: 8457420
• MDR Text Key: 140042654
• Report Number: 3010532612-2019-00074
• 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: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F18K0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THE PATIENT IS VENTILATED AND SEDATED.; THE PATIENT IS VENTILATED AND SEDATED.; THE PATIENT IS VENTILATED AND SEDATED.