MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0576-01

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

Complete initial reporter name: (b)(6), rn. The device was not returned and could not be evaluated. It was discarded by the user. We are unable to confirm the reported event. If new information becomes available, a supplemental report will be submitted. Complaint record id # (b)(4).

Event Description

It was reported that during insertion of the intra-aortic balloon (iab), the customer could not advance the iab any further. The console was started and it was noticed that only half of the iab was inflating. The iab was removed and replaced with a new one which worked normally without issue. There was no patient harm or adverse event reported.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: dorota wolpiuk ; 15 law drive; fairfield, NJ
• MDR Report Key: 11588749
• MDR Text Key: 242952097
• Report Number: 2248146-2021-00198
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112327
• 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: 05/14/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000131135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/14/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2020
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial