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

Lot Number 3000307872

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 04/20/2023

Event Type  malfunction  

Event Description

Inner lumen noted to not have transduced pulsatile pressure and unable to aspirate.

Event Description

Inner lumen noted to not have transduced pulsatile pressure and unable to aspirate.

• Brand Name: SENSATION PLUS 8FR.
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 16952550
• MDR Text Key: 315459141
• Report Number: 16952550
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 04/29/2023

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 Lot Number: 3000307872
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/18/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Race: White