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

Catalog Number IAB-05840-LWS

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Injury (2348); Needle Stick/Puncture (2462)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was inserted for temporary help in the patient with cardiogenic shock and ventricular failure. The balloon worked properly, but then stopped and alarms were received. The staff performed "raz" and restarted each time. After a few unsuccessful tries, and the hemodynamic data of the patient were deteriorating, a second balloon was inserted in the right femoral. As a result, the iab was removed and a second iab was successfully used.

Manufacturer Narrative

(b)(4). Teleflex did not receive the device for investigation. The reported complaint that the iab/iabp "stopped and alarms were received" is not able to be confirmed. The root cause of the complaint is undetermined. If the product is returned at a later date, a full investigation of the sample will be completed. The reported complaint will be monitored for any developing trends. No further action required at this time.

Event Description

It was reported that the intra-aortic balloon (iab) was inserted for temporary help in the patient with cardiogenic shock and ventricular failure. The balloon worked properly, but then stopped and alarms were received. The staff performed "raz" and restarted each time. After a few unsuccessful tries, and the hemodynamic data of the patient were deteriorating, a second balloon was inserted in the right femoral. As a result, the iab was removed and a second iab was successfully used.

• 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: 9342878
• MDR Text Key: 167021358
• Report Number: 3010532612-2019-00410
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No