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 Filling Problem (1233); Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/27/2021

Event Type  malfunction  

Manufacturer Narrative

Additional reporter name: (b)(6), circulatory assistant manager.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy the console generated gas gain, gas loss, and auto-fill failure alarms every few minutes.The console was swapped out, but this did not resolve the issue.Troubleshooting did not resolve the issue and a chest x-ray showed the iab was in the correct position.There was no visible blood in the tubing.The iab was removed and replaced.There was no patient harm or adverse event reported.

Event Description

N/a.

Manufacturer Narrative

Device evaluation: the product was returned with the membrane completely unfolded and blood on the interior and 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 and pressure tubing were also returned.A kink was found on the catheter tubing approximately 43.2cm from the iab tip.Additionally a kink was found on the inner lumen and catheter tubing near the y-fitting approximately 75.9cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal, extender and pressure tubing was performed and two leaks were detected.One on the membrane approximately 19.8cm from the rear seal measuring 0.064cm in length.The other leak was found at the kinked location of the catheter tubing approximately 75.9cm from the iab tip.The reported problems was most likely triggered by the leaks found on the membrane and catheter tubing.The penetration found on the membrane appears to have been caused by a sharp object.The penetration found in the catheter tubing appears to have been caused by a severe kink flexing back and forth that eventually penetrated the tubing.We are unable to determine when this may have occurred.A non-conforming material report review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period jun-19 to jul-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).

• 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
• MDR Report Key: 12180406
• MDR Text Key: 261935806
• Report Number: 2248146-2021-00460
• 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: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2023
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000132558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Date Manufacturer Received: 09/09/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.
• Patient Age: 50 YR
• Patient Weight: 97