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

Model Number 0684-00-0576-01

Device Problems Inappropriate Waveform (2536); Optical Problem (3001)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/10/2022

Event Type  Injury  

Manufacturer Narrative

Complete initial reporter name: (b)(6). The device has not been returned to the manufacturer so we are unable to complete an evaluation. If provided we will send a supplemental report with our additional findings. Complaint record id # (b)(4). Device not returned.

Event Description

The following was reported via medwatch report # (b)(4). A patient that presented with chest pain was sent to the cath lab where it was identified that he had severe multi-vessel coronary artery disease (cad) that would require a coronary artery bypass graft (cabg). The intra-aortic balloon (iab) was inserted for ongoing chest discomfort that could not be relieved with antianginals. It was reported that the fiber optic cable was not functioning properly and was unable to sense pressure or timing. They were unable to visualize the waveform or augment pressures. It was noted that the appropriate cables were not available to attach to the transducer. Approximately two days later, the patient was taken to the or where a transesophageal echocardiogram (tee) was completed and showed a possible aortic tear/dissection. A computed tomography angiograph (cta) of the chest identified an aortic injury that was not present on the ct scan completed prior to iab insertion. The cabg was cancelled and iab was removed.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 14223148
• MDR Text Key: 290462154
• Report Number: 2248146-2022-00330
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: 10607567108605
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000176825
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/10/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/27/2022 Patient Sequence Number: 1

Treatment

UNKNOWN PUMP.