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

Catalog Number 0684-00-0567

Device Problems Restricted Flow rate (1248); Inappropriate Waveform (2536); Optical Problem (3001)

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

Event Date 01/22/2024

Event Type  malfunction  

Manufacturer Narrative

The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint record id # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the console generated a fiber optic sensor failure message and the waveform was not displayed.It was noted that the central lumen of the iab was also clotted, and there were no other arterial lines available.The getinge representative advised that the console would need an alternate arterial line and listed the steps necessary to connect the pressure cable to a new transducer and zero.The customer confirmed they understood and contacted the physician.There was no patient harm or adverse event reported.

Event Description

It was reported that after approximately 4.5 days of intra-aortic balloon (iab) therapy, the console generated a fiber optic sensor failure message and the waveform was not displayed.The patient was not being moved when the failure occurred.It was noted that the central lumen of the iab was also clotted, and there were no other arterial lines available.The getinge representative advised that the console would need an alternate arterial line and listed the steps necessary to connect the pressure cable to a new transducer and zero.The customer confirmed they understood and contacted the physician.The iab was later removed after 4.5 days.There was no patient harm or adverse event reported.

Manufacturer Narrative

Device evaluation: the reported iab serial # (b)(6) but returned iab serial # (b)(6) and the returned iab was evaluated.The product was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter and partially covering the rear portion of the balloon.The returned sheath was not a maquet product.A portion of the extracorporeal tubing was cut from the iab and not returned.A kink was found on the catheter tubing approximately 35.3cm from the iab tip.The optical fiber was found to be broken within the membrane approximately 23.9cm from iab tip.The technician was able to successfully flush the inner lumen.The technician attempted to insert a laboratory 0.025¿ guide wire through the inner lumen and was able to successfully insert the guide wire.No obstructions were felt.The optical fiber was found to be broken, confirming the reported difficulty monitor the pressure and sensor failure.We are unable to determine when this may have occurred.The evaluation was not able to confirm the clotted inner lumen.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.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
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 18686138
• MDR Text Key: 335136171
• Report Number: 2248146-2024-00082
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122628
• 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
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000313122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 102 KG