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

Catalog Number 0684-00-0576-01

Device Problems Unraveled Material (1664); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2014

Event Type  malfunction  

Event Description

When the physician advanced the 8fr 50cc balloon into the 8.5fr sheath, he was met with resistance.Doctor then withdrew the balloon and found it slightly unwrapped.It then would not pass.The physician removed the device and used a new balloon to complete the procedure.There was no harm or injury to the patient.

• Brand Name: SENSATION PLUS
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfiled NJ 07004
• MDR Report Key: 3755412
• MDR Text Key: 4463323
• Report Number: 3755412
• Device Sequence Number: 1
• Product Code: DSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/28/2014

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: Physician
• Device Catalogue Number: 0684-00-0576-01
• Device Lot Number: 3045
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/17/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1