MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0433

Device Problems Display or Visual Feedback Problem (1184); Filling Problem (1233); Leak/Splash (1354); Material Deformation (2976); Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/25/2019

Event Type  malfunction  

Manufacturer Narrative

Complete event site name - (b)(6). Additional initial reporter - (b)(6), charge nurse & amber bedside rn. The product has been returned to the manufacturer, but is pending investigation. Once the investigation is completed a supplemental report with our findings will be submitted. (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy on a heart failure patient, the customer had kinked the balloon and noticed an audible hiss when attempting to fill the iab. The console alarmed auto-fill failure and leak in iab circuit. There was no visible blood in the tubing. The physician was on the way in to remove the balloon as a result of their conclusion that there was a fracture in the balloon shaft at the point of the kink and hissing. Patient taken to ccl for balloon replacement. The insertion was reported to be axillary, which is not the method described in the device instructions for use. There was no reported injury to the patient.

• Brand Name: SENSATION 7FR. 34CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 8509243
• MDR Text Key: 142522666
• Report Number: 2248146-2019-00293
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/07/2021
• Device Catalogue Number: 0684-00-0433
• Device Lot Number: 3000085808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: YR
• Event Location: No Information
• Date Manufacturer Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage