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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0567
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 06/06/2020
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.Complaint record id # (b)(4).
 
Event Description
It was reported that the patient had chest pain that started yesterday night and become severe.Upon arrival to hospital the patient developed acute pulmonary edema and was intubated.The patient arrested with three episodes of ventricular tachycardia (vt), shocked, followed by pulseless electrical activity (pea), and cardiopulmonary resuscitation (cpr) was done for 23 minutes.They shifted the patient to cath lab and also performed cpr there.Percutaneous coronary intervention (pci) done to mlad (100% thrombotic occlusion) and it was successful but pci to om2 (100% thrombotic occlusion) failed to ensure good flow(timi 0 to 1).Intra-aortic balloon catheter(iabc) was inserted in the cath lab as the patient was in cardiogenic shock.Patient arrested again (asystole) after arrived to ccu(coronary care unit).Cpr started for more than 15 minute as acls(advanced cardiovascular life support) protocol.Return of spontaneous circulation (rosc) was not achieved.The cardiothoracic surgery team were contacted for emergency extracorporeal membrane oxygenation (ecmo) but was refused and the death was declared at 13:16 on (b)(6) 2020.It was also reported that during use the battery of the cs300 intra-aortic balloon pump (iabp) is damaged and out of its shape.The customer has not attributed the patient's death to the intra-aortic balloon (iab).There was no reported malfunction on the intra-aortic balloon catheter (iabc).A separate report has been submitted for the cs300 intra-aortic balloon pump (iabp) under mfg report number 2249723-2020-01587.
 
Event Description
It was reported that the patient had chest pain that started yesterday night and become severe.Upon arrival to hospital the patient developed acute pulmonary edema and was intubated.The patient arrested with three episodes of ventricular tachycardia (vt), shocked, followed by pulseless electrical activity (pea), and cardiopulmonary resuscitation (cpr) was done for 23 minutes.They shifted the patient to cath lab and also performed cpr there.Percutaneous coronary intervention (pci) done to mlad (100% thrombotic occlusion) and it was successful but pci to om2 (100% thrombotic occlusion) failed to ensure good flow(timi 0 to 1).Intra-aortic balloon catheter(iabc) was inserted in the cath lab as the patient was in cardiogenic shock.Patient arrested again (asystole) after arrived to ccu(coronary care unit).Cpr started for more than 15 minute as acls(advanced cardiovascular life support) protocol.Return of spontaneous circulation (rosc) was not achieved.The cardiothoracic surgery team were contacted for emergency extracorporeal membrane oxygenation (ecmo) but was refused and the death was declared at 13:16 on (b)(6) 2020.It was also reported that during use the battery of the cs300 intra-aortic balloon pump (iabp) is damaged and out of its shape.The customer has not attributed the patient's death to the intra-aortic balloon (iab).There was no reported malfunction on the intra-aortic balloon catheter (iabc).A separate report has been submitted for the cs300 intra-aortic balloon pump (iabp) under mfg report number 2249723-2020-01587.
 
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.Reference complaint #(b)(4).H3 other text : device was discard and not returned.
 
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.Reference complaint #(b)(4).H3 other text : device was discarded and not returned.
 
Event Description
It was reported that the patient had chest pain that started yesterday night and become severe.Upon arrival to hospital the patient developed acute pulmonary edema and was intubated.The patient arrested with three episodes of ventricular tachycardia (vt), shocked, followed by pulseless electrical activity (pea), and cardiopulmonary resuscitation (cpr) was done for 23 minutes.They shifted the patient to cath lab and also performed cpr there.Percutaneous coronary intervention (pci) done to mlad (100% thrombotic occlusion) and it was successful but pci to om2 (100% thrombotic occlusion) failed to ensure good flow(timi 0 to 1).Intra-aortic balloon catheter(iabc) was inserted in the cath lab as the patient was in cardiogenic shock.Patient arrested again (asystole) after arrived to ccu(coronary care unit).Cpr started for more than 15 minute as acls(advanced cardiovascular life support) protocol.Return of spontaneous circulation (rosc) was not achieved.The cardiothoracic surgery team were contacted for emergency extracorporeal membrane oxygenation (ecmo) but was refused and the death was declared at 13:16 on (b)(6) 2020.It was also reported that during use the battery of the cs300 intra-aortic balloon pump (iabp) is damaged and out of its shape.The customer has not attributed the patient's death to the intra-aortic balloon (iab).There was no reported malfunction on the intra-aortic balloon catheter (iabc).A separate report has been submitted for the cs300 intra-aortic balloon pump (iabp) under mfg report number 2249723-2020-01587.
 
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Brand Name
SENSATION PLUS 7.5FR. 40CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key10607489
MDR Text Key209210438
Report Number2248146-2020-00514
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 02/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number0684-00-0567
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CS300 SI245594K6; CS300 SI245594K6
Patient Outcome(s) Death;
Patient Age36 YR
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