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

Catalog Number 0684-00-0575

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 05/03/2018

Event Type  malfunction  

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 # (b)(4), record # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy there was a catheter restriction alarm generated.There was no indication of a leak.All connections were secure.Patient was flat which is suggestive of a possible kink in catheter.The patient had no unusual movement prior to alarm and was not on a ventilator.During the troubleshooting call the physician came in to assess the situation and the patient began coding.The physician tried repositioning the catheter with no improvement.After 45 minutes the patient became stable, the physician stated the patient's hemodynamics were good and was going to have the support discontinued.Patient was scheduled to go to the operating room and went for surgery about 30 minutes later.

Manufacturer Narrative

Changed from: adverse event and product problem to: product problem removed life threatening corrected the narrative to remove all information indicating there was a patient injury and added that there was no injury to the patient, also clarified kink information.Changed from: serious injury to: malfunction (b)(4).(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy there was a catheter restriction alarm generated.There was no indication of a leak.All connections were secure.Patient was reported to be flat when it was suggested there might be a kink in catheter.It was then reported that the patient had no unusual movement prior to the alarm and was not on a ventilator.During the troubleshooting call the physician came in to assess the situation.The physician tried repositioning the catheter with no improvement.After 45 minutes the emergency service specialist called back and the physician stated the patient's hemodynamics were good and was going to have the support discontinued.Patient was scheduled to go to the operating room and went for surgery about 30 minutes later.There was no reported injury to the patient.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 7540636
• MDR Text Key: 109151324
• Report Number: 2248146-2018-00354
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2021
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000065642
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 05/30/2018
• Date Device Manufactured: 01/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 76 YR
• Patient Weight: 78