MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0575

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Pressure Problem (3012)

Patient Problems Cardiac Arrest (1762); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/16/2022

Event Type  Death  

Manufacturer Narrative

Complete event site name: (b)(6) hospital.Occupation: administrator/ supervisor, biomedical engineering manager.(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.(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy the patient expired due to illness.There was no malfunction of the iab reported.

Manufacturer Narrative

(b)(6).Device available for eval? changed from 'no' to 'yes' return to manufacture date manufacture date device not eval provide code health effect ¿ clinical code medical device ¿ problem code investigation findings investigation conclusions event site name, event site address, event site city, event site postal code 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 intra-aortic balloon (iab) therapy the augmentation suddenly doubled from the low 100s to the 200s.It was also noted that the arterial line waveform did not match the indices on the console.The customer stated that the indices displayed the systolic pressure much higher than it actually was and the patient was switched from iv levophed to iv nitroglycerin to manage blood pressure.The patient was post myocardial infarction (mi) and in cardiogenic septic shock.At some point during therapy, the patient cardiac arrested, was coded and expired.Patient expiration ruled due to illness.

Manufacturer Narrative

Additional information: event description updated.Device evaluation: the product was returned with the membrane completely unfolded with blood on the exterior of the catheter and between the catheter the returned non-maquet sheath.The extender tubing and pressure tubing were also returned.A catheter tubing kink was observed at approximately 60.5cm from the iab tip.Additionally, a catheter tubing/inner lumen kink was also observed at approximately 63.5cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal, extender and pressure tubing was performed and no leaks were detected.A sensor output test was performed and a pressure reading could not be obtained.An optical fault locator was used to detect any breaks along the optical fiber¿s length no breaks were observed.The evaluation confirmed the reported difficulty monitoring the pressure waveform.However, we are unable to determine how this sensor failure may have occurred and has been escalated to respective supplier to determine a root cause.A non-conforming material report review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint #(b)(4).

Event Description

It was reported that after approximately six days of intra-aortic balloon (iab) therapy the augmentation suddenly doubled from the low 100s to the 200s.It was also noted that the arterial line waveform did not match the indices on the console.The customer stated that the indices displayed the systolic pressure much higher than it actually was and the patient was switched from iv levophed to iv nitroglycerin to manage blood pressure.The patient was post myocardial infarction (mi) and in cardiogenic septic shock.At some point during therapy, the patient cardiac arrested, was coded and expired.Patient expiration ruled due to illness.

• Brand Name: SENSATION PLUS 8FR. 50CC 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: 14074751
• MDR Text Key: 289003304
• Report Number: 2248146-2022-00289
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2023
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000138015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 04/11/2022
• Supplement Dates Manufacturer Received: 04/04/2022; 06/02/2022
• Supplement Dates FDA Received: 04/18/2022; 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: CS100.; CS300 / SA04446-I5 & CS300 / SI151703A9.
• Patient Outcome(s): Death
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 89 KG