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

Catalog Number 0684-00-0575

Device Problems Filling Problem (1233); Leak/Splash (1354); Difficult to Remove (1528); Obstruction of Flow (2423); Gas/Air Leak (2946)

Patient Problem Injury (2348)

Event Date 06/13/2019

Event Type  Injury  

Manufacturer Narrative

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

It was reported that during intra-aortic balloon (iab) therapy, the clinicians had noted a brownish fluid in the helium tubing but continued to pump with a second console.Pumping continued for at least five more hours when the iabp alarmed gas loss, autofill failure and catheter restriction causing the user to contact the cardiologist who took the patient to the cardiac cath lab and attempted to remove the balloon.The doctor was unable to remove it and the patient was taken to the cvor (cardiovascular operating room)to remove the iab.

• 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 07004
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 8752754
• MDR Text Key: 149781829
• Report Number: 2248146-2019-00573
• Device Sequence Number: 1
• Product Code: DSP
• 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: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/01/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2022
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000092766
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 99