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

Catalog Number 0684-00-0575

Device Problem Restricted Flow rate (1248)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2019

Event Type  malfunction  

Manufacturer Narrative

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.Complaint record id # (b)(4).

Event Description

It was reported during intra-aortic balloon(iab) therapy, the console generated a check iab catheter alarm.The balloon was removed and replaced.There was no reported injury to the patient.

Manufacturer Narrative

Updated sections: a4, b4, g4, g7, h2, h3, h6, h10.The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter.One kink was found on the catheter tubing near the y-fitting approximately 75.4cm from the iab tip.The optical fiber was found to broken at this location.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and pumped for two hours which represents one complete autofill cycle.The iab pumped normally and no alarm sounded from the pump.The evaluation determined a kink in the catheter and optical fiber break.It is difficult to determine when or how a kink in the catheter and optical fiber break occurs.Although we did not repeat the event in the laboratory setting, a kink in the catheter can cause inflation difficulty or an alarm.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Complaint record # (b)(4).

Event Description

It was reported during intra-aortic balloon(iab) therapy, the console generated a check iab catheter alarm.The balloon was removed and replaced.There was no reported injury to the patient.

• Brand Name: SENSATION PLUS 8FR. 50CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 9560030
• MDR Text Key: 188207182
• Report Number: 2248146-2020-00007
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2022
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000105002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/07/2020
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 132