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 Optical Problem (3001); Pressure Problem (3012)

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

Event Date 11/30/2023

Event Type  malfunction  

Manufacturer Narrative

Event site postal code - 1450 the device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id # (b)(4).Device not returned.

Event Description

It was reported that after inserting the intra-aortic balloon (iab) and initiating therapy at 3am, the console generated a fiber optic sensor failure alarm and the pressure readings were not displayed.The patient was assisted using ecg trigger 1:1 ration.At 05h20 the customer decided to insert a new iab as the alarm had continued.After inserting the second iab, a pressure waveform was visible but they were unable to calibrate.Ecmo therapy was initiated.The customer swapped out the pump twice but the same alarms continued.It was decided to remove the iab and keep the patient on ecmo.Later that day, they decided to insert a third iab in addition to ecmo therapy.It was requested to source transducer cables as the surgeon wanted to utilize the inner lumen as a pressure source in case of fiber optic (fo) failure.A third iab was inserted via a sheath in the right femoral artery.After successful insertion of the iab, the fo sensor was connected, the pump recognized the fo input and therapy was started.After startup there was still no pressure curve and manual calibration was done with no effect.The pump generated an unable to calibrate optical sensor alarm.It was then decided to switch over to conventional transducer as pressure source which was successful.There was no patient harm or adverse event reported.This report is for the first iab used in this event.Separate reports will be submitted for the second and third iabs.

Event Description

It was reported that after inserting the intra-aortic balloon (iab) and initiating therapy at 3am, the console generated a fiber optic sensor failure alarm and the pressure readings were not displayed.The patient was assisted using ecg trigger 1:1 ration.At 05h20 the customer decided to insert a new iab as the alarm had continued.After inserting the second iab, a pressure waveform was visible but they were unable to calibrate.Ecmo therapy was initiated.The customer swapped out the pump twice but the same alarms continued.It was decided to remove the iab and keep the patient on ecmo.Later that day, they decided to insert a third iab in addition to ecmo therapy.It was requested to source transducer cables as the surgeon wanted to utilize the inner lumen as a pressure source in case of fiber optic (fo) failure.A third iab was inserted via a sheath in the right femoral artery.After successful insertion of the iab, the fo sensor was connected, the pump recognized the fo input and therapy was started.After startup there was still no pressure curve and manual calibration was done with no effect.The pump generated an unable to calibrate optical sensor alarm.It was then decided to switch over to conventional transducer as pressure source which was successful.There was no patient harm or adverse event reported.This report is for the first iab used in this event.A separate report for the second iab was submitted under mgf report number 2248146-2024-00013.Another separate report for the third iab was submitted under mfg report number 2248146-2024-00015.

Manufacturer Narrative

Photographs and videos were provided by the account.The videos show a failed fiber optic test on the system diagnostics screen of the cardiosave hybrid display.The photos provided include pictures of the display with unable to calibrate optical sensor and fiber optic sensor failure, as well as the system fault logs, which show record of augmentation alarms, no trigger, no pressure trigger, and poor signal alarms.Based on the photographs and videos provided by the facility, the reported failures are confirmed.However, no decon or visual inspection was performed since the product was not returned and could not be evaluated.Therefore, we are unable to determine a root cause for the reported failures.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.Reference complaint #(b)(4).

Event Description

It was reported that after inserting the intra-aortic balloon (iab) and initiating therapy at 3am, the console generated a fiber optic sensor failure alarm and the pressure readings were not displayed.The patient was assisted using ecg trigger 1:1 ration.At 05h20, after approximately one hour of therapy, the customer decided to insert a new iab as the alarm had continued.After inserting the second iab, a pressure waveform was visible but they were unable to calibrate.Ecmo therapy was initiated.The customer swapped out the pump twice but the same alarms continued.After approximately one hour of therapy, it was decided to remove the iab and keep the patient on ecmo.Later that day, they decided to insert a third iab in addition to ecmo therapy.It was requested to source transducer cables as the surgeon wanted to utilize the inner lumen as a pressure source in case of fiber optic (fo) failure.A third iab was inserted via a sheath in the right femoral artery.After successful insertion of the iab, the fo sensor was connected, the pump recognized the fo input and therapy was started.After startup there was still no pressure curve and manual calibration was done with no effect.The pump generated an unable to calibrate optical sensor alarm.It was then decided to switch over to conventional transducer as pressure source which was successful.The iab was removed after three days of therapy.There was no patient harm or adverse event reported.This report is for the first iab used in this event.A separate report for the second iab was submitted under mgf report number 2248146-2024-00013.Another separate report for the third iab was submitted under mfg report number 2248146-2024-00015.

Manufacturer Narrative

Gfe response received 28feb2024 - updated field(s): age at time of event / age units (patient); describe event or problem; concomitant products; report source.The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id # (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: 18440948
• MDR Text Key: 331867075
• Report Number: 2248146-2024-00009
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: 10607567108605
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000330296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 01/10/2024; 02/28/2024
• Supplement Dates FDA Received: 01/11/2024; 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EDWARDS TRANSDUCER
• Patient Age: 45 YR
• Patient Sex: Male