MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON(IAB); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number UNKNOWN

Device Problems Calibration Problem (2890); Pressure Problem (3012)

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

Event Date 11/30/2023

Event Type  malfunction  

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 third iab used in this event.Separate reports have been submitted for the first iab under 2248146-2024-00009 and for the second iab under mfg report number 2248146-2024-00013.

Manufacturer Narrative

Event site postal code (b)(6).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).

Manufacturer Narrative

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

Event Description

N/a.

Manufacturer Narrative

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).

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 third iab used in this event.Separate reports have been submitted for the first iab under 2248146-2024-00009 and for the second iab under mfg report number 2248146-2024-00013.

• Brand Name: UNKNOWN INTRA-AORTIC BALLOON(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: 18451456
• MDR Text Key: 332286548
• Report Number: 2248146-2024-00015
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,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

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• 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