MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 7.5FR. 40CC IAB WITH ACCESSORIES, US ONLY; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0568-01U
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Foreign Body In Patient (2687)
Date of Event	12/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had an iabp placed prior to a cabg surgery.Following, the iabp became loud and blood was baking up into the tubing.The balloon had ruptured inside of patient.Surgeon removed catheter and placed a new one.The next day, iabp began alarming to "check catheter" when in 1:1.It ran without issue on 1:2.Iabp helium tubing was noted to have blood flecks in it.The balloon had ruptured again inside of patient.The provider attempted to remove the iabp through the sheath and the catheter fractured.Sheath and remaining portion of catheter were then removed.Pts.Blood pressure decreased during manual compression requiring albumin, levophed and dobutamine.Hemoglobin dropped from 9.4 to 7.1 by the following morning.Pt.Required 1 unit of prbcs.

• Brand Name: SENSATION PLUS 7.5FR. 40CC IAB WITH ACCESSORIES, US ONLY
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• MDR Report Key: 8168740
• Report Number: 8168740
• Device Sequence Number: 1280038
• Product Code: DSP
• UDI-Device Identifier: 10607567109565
• UDI-Public: (01)10607567109565
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/07/2018
• Report Date (Section F): 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 0684-00-0568-01U
• Device Catalogue Number: 0684-00-0568-01U
• Device Lot Number: 30000550380302
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Weight: 109
• Date Report Sent to FDA: 12/07/2018