MAUDE Adverse Event Report: DATASCOPE FAIRFIELD UNKNOWN INTRA AORTIC BALLOON; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number UNKNOWN

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Calcium Deposits/Calcification (1758); Death (1802); Low Blood Pressure/ Hypotension (1914); Collapse (2416)

Event Date 11/12/2017

Event Type  Death  

Manufacturer Narrative

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

The manufacturer received facility medwatch report # (b)(4) on 19mar2018.The reported event description was: "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 (cardiopulmonary resuscitation) 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 (ventricular tachycardia) or v-fib (ventricular fibrillation).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 normal sinus rhythm after several episodes of shock.We proceeded 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 left ventricle.It was at that time we elected to call death on the patient.Iapbp was not working correctly may been because of trying to float with limited cardiac output.During the cutdown 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 vessel was collapsed due to limited cardiac output." this report is for the second intra-aortic balloon (iab) catheter that was attempted to be placed.The facility medwatch report does not list the serial number, the lot number, or product name associated with the second iab catheter.Please note where customer mentions insertion of intra-aortic balloon (iab) pump and/or iapbp, it is in reference to the iab catheter.The first intra-aortic balloon (iab) catheter has been reported on manufacturer's medical device report 2248146-2017-00684.The patient is reported to have expired, but the date of death is unknown at this time.

• Brand Name: UNKNOWN INTRA AORTIC BALLOON
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 7432864
• MDR Text Key: 105559119
• Report Number: 2248146-2018-00262
• 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: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Required Intervention