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

Catalog Number 0684-00-0575

Device Problems Display or Visual Feedback Problem (1184); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2018

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.(b)(4).

Event Description

It was reported that there were multiple alarms generated "fiber-optic sensor failure", "gas loss", and "transducer" during intra-aortic balloon (iab) therapy.The customer stated the iab pump (iabp) was switched, but there were still multiple failures.The customer states there were 2 places just below the rear of the iab that were kinked.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.The sensor cable and connector was cut from the device and not returned.Three kinks were observed on the catheter tubing approximately 27.9cm, 31cm and 75.9cm from the iab tip.The optical fiber was found to be broken at the kinked location of 31cm.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 confirmed the reported kink in the catheter and the optical fiber break confirming the reported fiber optic sensor failure alarm.We were unable to duplicate the reported ¿gas gain¿ alarm.It is difficult to determine when or how a kink in the catheter occurs.Although we did not repeat the gas gain alarm 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 # (b)(4), record # (b)(4).

Event Description

It was reported that there were multiple alarms generated "fiber-optic sensor failure", "gas loss", and "transducer" during intra-aortic balloon (iab) therapy.The customer stated the iab pump (iabp) was switched, but there were still multiple failures.The customer states there were 2 places just below the rear of the iab that were kinked.There was no reported injury to the patient.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 8183934
• MDR Text Key: 131012772
• Report Number: 2248146-2018-00738
• 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: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2021
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000080686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Device Age: YR
• Date Manufacturer Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 91