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

Catalog Number 0684-00-0434

Device Problems Inability to Auto-Fill (1044); Gas/Air Leak (2946); Optical Problem (3001); Migration (4003)

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

Event Date 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

Additional initial 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 the patient was turned causing the helium tubing to disconnect.The pump then generated fiber optic sensor failure and autofill failure alarms and they could not resume pumping.The customer says they have been transducing the central lumen of the fiber optic (fo) iab because the fo had failed previously.The customer did not know what had actually gone wrong with the fo.The getinge representative asked them to reconnect and press start again.There was an arterial line waveform present, but the autofill failure message appeared again.It was then suggested they order a chest film stat and try log rolling the patient while pressing fill.This worked and the pump resumed.Several minutes later the pump showed "gas loss" and they were unable resume.The "autofill failure" happened again as well.There was no blood in the helium tubing.It was suggested that they check location, and a physician may be able to manipulate the iab but that it is likely the iab will need to be removed.The customer then stated that the iab had been in for over two weeks and they have had ongoing issues with gas loss alarms during that time.The iab was replaced and two days later, the patient went to surgery.A few hours post-op, the console started alarming but was not replaced.There was no patient harm or adverse event reported.

Manufacturer Narrative

Reference complaint #(b)(4).

Event Description

N/a.

Manufacturer Narrative

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 not a maquet product.The pressure tubing and extender tubing was also returned.A kink was found on the catheter tubing and inner lumen near the y-fitting approximately 76.5cm from the iab tip.The inner lumen was found occluded with dried blood.The occlusion was unable to be cleared.A sensor output test was performed and the sensor was found to be within specification.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal, pressure and extender tubing was performed and no leaks were detected.The iab was placed on the cardiosave pump and the iab fully inflated and deflated.The iab then pumped for two hours which represents one complete autofill cycle and a gas loss in iab circuit alarm occurred on the pump.The condition of the iab as received indicated a kink in the catheter tubing and inner lumen.We are unable to determine when the kink occurred, however the kink found on the catheter tubing of the returned device restricted the gas passage and resulted in the gas loss alarm.The evaluation confirmed the reported gas loss alarm.The reported sensor failure cannot be confirmed by the evaluation.Although a kink may cause an autofill alarm we were unable to duplicate the alarm.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 7FR. 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: 18450111
• MDR Text Key: 332170200
• Report Number: 2248146-2024-00014
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• 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,Followup
• Report Date: 04/25/2024

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: 0684-00-0434
• Device Lot Number: 3000318686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 94 KG