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

Catalog Number 0684-00-0575

Device Problems Unraveled Material (1664); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2020

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 record id # (b)(4).

Event Description

It was reported during insertion of the intra-aortic balloon (iab), the balloon would not pass through the sheath and balloon was unwrapped.Another balloon was opened and utilized.There was no reported injury to the patient.

Event Description

It was reported during insertion of the intra-aortic balloon(iab), the balloon would not pass through the sheath and balloon was unwrapped.Another balloon was opened and utilized.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane completely unfolded with traces of blood on the exterior of the catheter.The one-way valve and syringe were also returned still attached to the extracorporeal tubing.A catheter tubing kink was observed at approximately 67.3cm from the iab tip.At this same location, an optical fiber break was also observed.The one-way valve was vacuum tested and it held vacuum.A laboratory insertion test was unable to be performed due to the returned condition of the iab.A 0.025¿ laboratory guidewire was inserted into the inner lumen and was found to be clear, no obstruction were felt.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The evaluation cannot confirm the reported problem due to the returned condition of the iab.We are unable to 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).

• 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: 10075057
• MDR Text Key: 196847526
• Report Number: 2248146-2020-00259
• 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: 06/19/2020

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: 12/09/2022
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000110617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/20/2020
• Supplement Dates Manufacturer Received: 06/12/2020
• Supplement Dates FDA Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 113