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 Filling Problem (1233); Calibration Problem (2890)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Pneumothorax (2012); Cardiac Tamponade (2226); Low Cardiac Output (2501); Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 05/25/2021

Event Type  Death  

Manufacturer Narrative

The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id # (b)(4).

Event Description

It was reported that once the patient had returned from a coronary artery bypass graft (cabg) x8, he had significant bleeding shown on his computerized tomography (ct) scans.Approximately four hours later, the patient was administered calcium chloride.Intravenous pyelogram (ivp) showed low heartrate (hr), low sustained virologic response (svr), low cardiac output (co), and low blood pressure (bp).An echocardiogram was done at bedside and revealed the patient had cardiac tamponade.The final report showed left ventricular ejection fraction (lvef) was 30% with anterior and apical akinesis of the left ventricle as well as mild mitral regurgitation (mr) and tricuspid regurgitation (tr).There was also a trivial pericardial effusion and some element of a pleural effusion.Another chest x-ray was done showing a tiny right apical pneumothorax and a pneumopericardium.As the patient's status continued to decline, the physician emergently inserted the intra-aortic balloon (iab).After insertion of the iab, the console indicated that there was an auto-fill failure, unable to calibrate optic sensor, and to check the iab.After about two minutes, the decision was made to remove the iab and insert a new one.The second iab was connected and began to work successfully.After approximately one hour, the patient coded and pulseless electrical activity (pea) cardiopulmonary resuscitation (cpr) was started.The patient expired about one hour later due to sudden cessation of cardiac activity with no return of cardiac activity even after iab placed, placing pacer on pressors, administering fluids, and blood.This report is for the first iab used in this event.A separate report will be submitted for the second iab.

Event Description

N/a.

Manufacturer Narrative

Correction to health effect ¿ clinical code.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id # (b)(4).

Manufacturer Narrative

The product was returned with the membrane completely unfolded with blood on the exterior of the catheter.A kink was also found at 39.62 cm from the iab tip.An underwater leak test of the balloon, catheter tubing, y-fitting and extracorporeal tubing was performed and no leaks were detected.A sensor output test of the optical fiber was performed and was found to be within specifications.The iab was placed on the cs300 pump and fully inflated.No alarm sounded from the pump.The evaluation did not confirm the reported problems.Although we did not repeat this event in the laboratory setting, a kink in the catheter may cause inflation difficulty, inability for the fiber optic to calibrate, and alarms.It is difficult to determine when or how a kink in the catheter occurred.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.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 jun-2019 through may-2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.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: 12012985
• MDR Text Key: 256637464
• Report Number: 2248146-2021-00386
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567106779
• UDI-Public: 10607567106779
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2022
• Device Model Number: 0684-00-0470-01
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000089609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 82 KG