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 Difficult to Flush (1251); Inappropriate Waveform (2536); Optical Problem (3001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2023

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 record id # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the console displayed a fiber optic sensor failure message.The customer was walked through steps to disconnect the fiber optic cable and transduce the central lumen of the iab, but the waveform was very dampened.The lumen was sluggish to flush.A bedside radial arterial line offered a much better waveform and the console was switched to that arterial line successfully.There was no patient harm or adverse event reported.

Manufacturer Narrative

Additional email: (b)(6).Additional reporter: (b)(6).

Event Description

It was reported that after approximately 4.5 - 5 days of intra-aortic balloon (iab) therapy, the console generated a fiber optic sensor failure alarm.After one turn, the console went into standby and automatically switched from an ecg trigger to pressure trigger (without a change in heart rhythm or rate).It was noted that the patient was being moved when the failure occurred, requiring the console to be placed in stand-by and the iab manually re-inflated.At this time, there was a good arterial waveform and no iab waveform.The customer was unable to take the console out of standby so they switched to another console from the cath lab.Upon switching to the new console the arterial waveform was poor.The customer was walked through steps to disconnect the fiber optic cable and transduce the central lumen of the iab, but the waveform was very dampened.The lumen was sluggish to flush.A bedside radial arterial line offered a much better waveform and the console was switched to that arterial line successfully.There was no patient harm or adverse event reported.

Event Description

N/a.

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #: (b)(4).

• 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: 16902176
• MDR Text Key: 314903784
• Report Number: 2248146-2023-00317
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000287427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 82 KG