MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0568-01

Device Problems Off-Label Use (1494); Calibration Problem (2890); Material Deformation (2976)

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

Event Date 07/14/2021

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.(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the console generated an unable to calibrate optical sensor alarm.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The customer was made aware of the off-label use and proceeded to troubleshoot as though it were a femoral insertion.Screenshots of console screen revealed it was functioning appropriately with an excellent, crisp arterial wave form and good afterload reduction.The customer mentioned that therapy had been started for over a week and they had not had any issues until today after the patient ambulated.It was noted that the fluid lumen had never been set up making it unusable and patient did not have another line.Cardiology fellow at the bedside ordered a chest film and stated that the catheter tip position had not changed.It was explained that due to the timing of the alarm, the catheter was likely kinked internally at some point.It was then suggested that they could put the pump in semi auto mode to silence the alarm.The customer opted to leave the pump as is.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 aug-19 through jul-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).

• Brand Name: SENSATION PLUS 7.5FR. 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: 12275378
• MDR Text Key: 264997814
• Report Number: 2248146-2021-00490
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: 10607567108063
• Combination Product (y/n): N
• PMA/PMN Number: K122628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

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: 08/20/2023
• Device Model Number: 0684-00-0568-01
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000129252
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 08/04/2021
• Supplement Dates Manufacturer Received: 10/26/2021
• Supplement Dates FDA Received: 10/26/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 68 YR
• Patient Weight: 63