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

Catalog Number 0684-00-0575

Device Problems Restricted Flow rate (1248); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2020

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.Complaint # (b)(4).

Event Description

It was reported during intra-aortic balloon(iab) therapy, blood was seen in the helium tubing and the console generated iab catheter restriction alarm.The patient is stable and a physician has been paged to remove the iab.The rn is unsure if another iab will be inserted.The iab is in the femoral artery.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane cut/separated in pieces, completely unfolded with blood on the exterior and interior of the catheter and between the catheter and the returned non-maquet sheath.The sheath was severely accordioned/ribbed.The optical fiber was observed to be broken at approximately 13cm from the iab tip.Additionally, inner lumen and catheter tubing kinks were also observed at approximately 23.9cm and 69.1cm from the iab tip respectively.An underwater leak test of the balloon, y-fitting and catheter tubing was unable to be performed due to the returned condition of the iab.However, a leak test of the extracorporeal tubing, extender tubing and pressure tubing was performed and no leaks were detected.Due to the returned condition of the iab, a complete leak test was unable to be performed.However, the presence of blood inside the iab confirms the reported problem.We are unable to conclusively determine how or when this may have occurred since we cannot mimic the clinical settings.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).

Event Description

It was reported during intra-aortic balloon(iab) therapy, blood was seen in the helium tubing and the console generated iab catheter restriction alarm.The patient is stable and a physician has been paged to remove the iab.The rn is unsure if another iab will be inserted.The iab is in the femoral artery.There was no reported injury to the patient.

• Brand Name: SENSATION PLUS 8FR. 50CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 10140351
• MDR Text Key: 198549932
• Report Number: 2248146-2020-00281
• 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: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2023
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000112935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 73