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

Catalog Number 0684-00-0575

Device Problems Inability to Auto-Fill (1044); Filling Problem (1233)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2019

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.(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, there was an auto fill failure alarm on the console.The iab was removed and customer pressed start button, the iab was able to auto fill outside of the patient body.The iab was replaced to continue therapy.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and no visible blood on the catheter.Two kinks were found on the catheter tubing approximately 45.7cm and 35.6cm from the iab tip.Two additional kinks were observed on the inner lumen within the membrane approximately 12.7cm and 11.4cm from the iab tip.The technician attempted to insert a 0.025¿ laboratory guide wire through the inner lumen and resistance was only felt at the kinked 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 an ¿augmentation below limit set¿ alarm occurred at 80bpm.The condition of the iab as received indicated a kink on the inner lumen and catheter tubing.Even though we did not replicate the reported alarm, a kink can cause the issue.The evaluation confirmed the problems.We are unable to conclusively determine when the kink may have occurred.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.Reference complaint #(b)(4); record id (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, there was an auto fill failure alarm on the console.The iab was removed and customer pressed start button, the iab was able to auto fill outside of the patient body.The iab was replaced to continue therapy.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 CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 8536932
• MDR Text Key: 142754938
• Report Number: 2248146-2019-00307
• 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: 06/12/2019

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: 10/19/2021
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000082762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/22/2019
• Supplement Dates Manufacturer Received: 05/24/2019
• Supplement Dates FDA Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1