MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-05830-LWS

Device Problems No Device Output (1435); Failure to Zero (1683)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when the intra-aortic balloon (iab) was connected to the intra-aortic balloon pump (iabp), the iab did not zero. The clinical technician tried a couple more times and had plugged the iab into another pump, but no change. As a result, the iab (30cc) was exchanged for another iab (40cc). The 40cc iab was used as there was not another 30cc iab available. Placement was checked to ensure left subclavian artery and renal arteries where not covered by longer balloon. Iabp (wave/fo) worked very well and patient had surgery and was discharged. There was no report of patient complication or serious injury and death.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 8515830
• MDR Text Key: 142045776
• Report Number: 3010532612-2019-00103
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/31/2019
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F18A0048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial