MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0470-01U

Device Problems Partial Blockage (1065); Entrapment of Device (1212); Device Displays Incorrect Message (2591)

Patient Problems Failure of Implant (1924); Thrombus (2101)

Event Date 01/05/2018

Event Type  malfunction  

Event Description

Intra-aortic balloon pump (iabp) was put in prior to coronary artery bypass graft (cabg) surgery.During surgery, the balloon pump console gave alarm and a small amount of blood was noticed in the helium line.The line was replaced and the alarms were cleared and the iabp began to function as normal.During patient's recovery (after cabg, in cardiac care unit [ccu]), the balloon pump console again gave an alarm.The doctor was called and he decided to remove balloon.Upon removal of the balloon, the surgeon was unable to get the balloon through the sheath.The patient had to be taken to the operating room for open surgical removal.An arterial cutdown was performed to remove the balloon, and "rock hard" clotted blood was found inside the balloon that was keeping it from deflating.The balloon was sent to pathology for evaluation.Manufacturer response for sensation 40cc 7fr fiber optic balloon cath, (per site reporter) : they will want to examine the balloon and initiate a quality control investigation.

• Brand Name: SENSATION 7FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• MDR Report Key: 7198931
• MDR Text Key: 97542947
• Report Number: 7198931
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 0684-00-0470-01U
• Device Catalogue Number: 0684-00-0470-01U
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR