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); Calibration Problem (2890)

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

Event Date 05/10/2018

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 intra-aortic balloon (iab) insertion in the ccl (cardiac catheterization laboratory) the iab would not calibrate and an "unable to calibrate fiber optic sensor" was generated.Calibration attempts were unsuccessful.The fiber optic waveform was present but no pressures indices were displayed since it would not calibrate.The physician stated there was no difficulty with insertion.The staff successfully converted to using the fluid lumen and a transducer to obtain the waveform and numbers.Approximately 5 hours later the bedside nurse reconnected the fiber optic cable once again to attempt calibration.This time a waveform and inappropriate indices appeared but the catheter would still not calibrate.The indication for use was stemi (anterior st myocardial infarction).There was no reported injury to the patient.

Event Description

It was reported that after intra-aortic balloon (iab) insertion in the ccl (cardiac catheterization laboratory) the iab would not calibrate and an "unable to calibrate fiber optic sensor" was generated.Calibration attempts were unsuccessful.The fiber optic waveform was present but no pressures indices were displayed since it would not calibrate.The physician stated there was no difficulty with insertion.The staff successfully converted to using the fluid lumen and a transducer to obtain the waveform and numbers.Approximately 5 hours later the bedside nurse reconnected the fiber optic cable once again to attempt calibration.This time a waveform and inappropriate indices appeared but the catheter would still not calibrate.The indication for use was stemi(anterior st myocardial infarction).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 returned sheath was over the catheter but it was not a maquet product.The pressure tubing was also returned.One kink was observed on the catheter tubing near the y-fitting approximately 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.Complaint # (b)(4), record # (b)(4).

• 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: 7545700
• MDR Text Key: 109741169
• Report Number: 2248146-2018-00362
• 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: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2021
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000067128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Device Age: YR
• Date Manufacturer Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 110