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

Catalog Number IAB-06840-U

Device Problems Complete Blockage (1094); No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the central lumen on the intra-aortic balloon (iab) clotted. The rn reported that the arterial pressure (ap) waveform on the pump went totally flat. The rn tried to aspirate from the central lumen but was not able to draw anything back at all. As a result, the central lumen was capped off and they connected the transducer to the sidearm of the sheath. It was also recommended by the clinical support specialist (css) that a radial arterial line be placed to use for the ap source. There was no report of delay in therapy. There was no report of patient complications, serious injury or death.

• Brand Name: 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: 8656297
• MDR Text Key: 146635497
• Report Number: 3010532612-2019-00160
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2020
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F18K0062
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial