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

Model Number IPN000254

Device Problems Fluid Leak (1250); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The report was received from a user facility report (ufr)/medwatch (b)(4). It was reported that blood flecks were noted in the helium line on the balloon pump (approximately 1 hours after arrival from the cath lab). After a few minutes later it was noted blood was pooling into the helium line. As a result, the intra-aortic balloon (iab) and pump were removed. There was no report of patient complications, serious injury or death. Additional information was received from the sales rep that the cath lab manager mentioned there was two iab ruptures since (b)(6) 2019. This is the first iab of the two iab that the sales representative reported had ruptured.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• 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: 9775485
• MDR Text Key: 184874655
• Report Number: 3010532612-2020-00022
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/23/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: IPN000254
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial