MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0567

Device Problems Device Inoperable (1663); Invalid Sensing (2293)

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

Event Date 02/27/2018

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 while supporting the patient on intra-aortic balloon (iab) therapy the fiber optic sensor stopped working.Compared with the noninvasive blood pressure amplifier (nibp) and transducing to the bedside monitor the console was giving a poor, inaccurate results.Central lumen was transduced to the iab pump and pressures were accurate.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 and partially covering the rear portion of the balloon.The extender tubing was also returned.One kink was found on the inner lumen approximately 3.8cm form the iab tip.Three kinks were found on the catheter tubing approximately 37.3cm, 48.5cm, 58.2cm and 76.2cm from the iab tip.The inner lumen was found to be occluded with dried blood.The occlusion was able to be cleared.The sensor cable was returned cut in two parts.Visual inspection was performed on the catheter and no breaks were detected on the optical fiber.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and no leaks were detected.Due to the damaged sensor cable a sensor output test was unable to be performed.The condition of the iab as received indicated a damaged sensor cable, kinks on the inner lumen and catheter tubing.However we were unable to test the complete iab catheter for the reported problem due to its returned condition.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 while supporting the patient on intra-aortic balloon (iab) therapy the fiber optic sensor stopped working.Compared with the noninvasive blood pressure amplifier (nibp) and transducing to the bedside monitor the console was giving a poor, inaccurate results.Central lumen was transduced to the iab pump and pressures were accurate.There was no reported injury to the patient.

• Brand Name: SENSATION PLUS 7.5FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 7370186
• MDR Text Key: 103595537
• Report Number: 2248146-2018-00200
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K122628
• 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: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000023051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Device Age: YR
• Date Manufacturer Received: 03/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 72