MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Lot Number 30000181420237

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Calcium Deposits/Calcification (1758); Death (1802); Low Blood Pressure/ Hypotension (1914); Low Cardiac Output (2501)

Event Date 11/12/2017

Event Type  Death  

Event Description

The patient's skin was closed after open-heart surgery.Anesthesia noted that there was approximately 20 minutes after the skin was closed that the patient began becoming hypotensive.He initiated giving the patient fluids as well as pressor support with marginal response.Cpr including chest compressions was initiated as well as vasoactive and pressor and fluid support.We attempted to place intraaortic balloon pump (iabp).The first balloon pump was inserted but the balloon pump itself was not functioning.We attempted to place a second balloon pump, however due to the patient's significant peripheral vascular disease, the balloon pump would not float.We then proceeded to cut down to the femoral artery to try to place it directly into the artery and that is when we noted again that there were severe calcifications of the artery, not allowing us to place the balloon pump.We then elected to go back on cardiopulmonary bypass.The patient was heparinized.The chest was opened.Transesophageal echocardiography (tee) at this time showed that there was decreasing contractility of the heart.During chest compressions, there were several times we were able to generate a shockable rhythm of being v-tach or v-fib.The patient had external pacers on and v-fib pacers due to his history of sustained v-tach.However, we were never able to convert the patient back into a normal sinus rhythm after several episodes of shock.We proceeded to begin to put the patient back on pump but a final look of the tee showed that now the patient had no more movement in his right or his left ventricle.It was at this time that we elected to call death on the patient.Iapbp as not working correctly may have been because of trying to float with limited cardiac output.During the cut down to insert the second balloon pump it was noted that the vessel was full of plaque and was not able to access vessel and that the vessel was collapsed due to limited cardiac output.

• Brand Name: SENSATION
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law dr.; fairfield NJ 07004
• MDR Report Key: 7312804
• MDR Text Key: 101513365
• Report Number: 7312804
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Lot Number: 30000181420237
• Other Device ID Number: 7 FR 40 CC
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 65 YR
• Patient Weight: 75