MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0470-01

Device Problems Inability to Auto-Fill (1044); Inappropriate Waveform (2536)

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

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

Complete event site name: (b)(6).Complete initial reporter name: (b)(6).Additional reporter name: (b)(6).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 generated an auto-fill failure alarm that would not resolve with basic troubleshooting.The catheter tip position was verified via chest x-ray.The console was swapped out for a different one, but this did not resolve the issue.After changing the console, it immediately generated a leak in iab circuit alarm.The bedside nurse performed an iab fill and reduced the augmentation setting by two bars which allowed the pump to restart.The patient was alert and oriented but moving a great deal per the nurse.It was noted that the alarm was consistent with patient movement.A screenshot of the console monitor revealed an unreliable electrocardiogram (ecg) waveform, the console switching back and forth between ecg and pressure triggers, as well as round/flattened balloon waveform peaks.The nurse removed and replaced the ecg patches and added a touch of doppler gel which corrected ecg waveform and trigger issues.The iab was then removed and replaced successfully.There was no patient harm or adverse event reported.

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period sep-2019 to aug-2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.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

N/a.

• Brand Name: SENSATION 7FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• MDR Report Key: 12533346
• MDR Text Key: 273359287
• Report Number: 2248146-2021-00630
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567106779
• UDI-Public: 10607567106779
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2021

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 Expiration Date: 12/08/2023
• Device Model Number: 0684-00-0470-01
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000138016
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 09/27/2021
• Supplement Dates Manufacturer Received: 10/19/2021; 10/19/2021
• Supplement Dates FDA Received: 10/19/2021; 10/19/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 53 YR
• Patient Weight: 63