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

Catalog Number 0684-00-0575

Device Problems Failure to Calibrate (2440); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2018

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 after approximately a day of intra-aortic balloon (iab) an "unable to calibrate" alarm was generated.The waveform was present but the pressures could not be monitored.Troubleshooting did not correct the problem.The console was already changed and the same alarm persisted.An alternate arterial source was used to obtain pressure indices.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 pressure tubing was also returned.Three kinks were found on the catheter tubing approximately 29.7cm, 72.9cm and 75.9cm from the iab tip.A sensor output test was performed and the sensor was found to be within specification.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and pressure tubing was performed and no leaks were detected.An evaluation of the product was unable to duplicate the reported problems.The product performed according to specification.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.(b)(4).

Event Description

It was reported that after approximately a day of intra-aortic balloon (iab) an "unable to calibrate" alarm was generated.The waveform was present but the pressures could not be monitored.Troubleshooting did not correct the problem.The console was already changed and the same alarm persisted.An alternate arterial source was used to obtain pressure indices.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
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 7376963
• MDR Text Key: 103948710
• Report Number: 2248146-2018-00208
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2021
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000065642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 91