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U.S. Department of Health and Human Services

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

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DATASCOPE FAIRFIELD UNKNOWN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Death (1802); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Nausea (1970); Renal Failure (2041); Vomiting (2144); Cardiogenic Shock (2262)
Event Date 02/28/2018
Event Type  malfunction  
Manufacturer Narrative
The device was not returned and could not be evaluated. It was discarded by the user. We are unable to confirm the reported event. If new information becomes available, a supplemental report will be submitted. (b)(4).
 
Event Description
It was reported that the patient presented to the emergency department from privately owned vehicle (ed pov) as a st elevation myocardial infarction (stemi) in cardiogenic shock. The patient was emergently taken to the catheter lab where the patient underwent percutaneous coronary intervention (pci) of the circulation (circ) with 2 drug-eluting stents (dess) and also had what appeared to be a chronic issue with right coronary artery (rca). They attempted to open the rca as well but were not successful. The patient was hypotensive throughout the procedure so an intra-aortic balloon (iab) was placed. When patient arrived to the coronary care unit (ccu) the nurse states that the patient was complaining of abdominal pain with nausea and vomiting (n/v). The nurse medicated him for this but symptoms continued. Approximately 3 hours after the iab was placed the patient was sent to commuted tomography (ct). The ct images showed that the iab was in the aorta and the opaque tip was located at the lumbar vertebrae 3 (l3) level and was occluding the origin of the superior mesenteric artery (sma) with resultant ischemic gut and diffuse portal and mesenteric venous gas. The iab was then emergently removed by the cardiologist. Approximate time the iab was in the patient was 3. 5 hours. The customer states there were no post placement of cine shots for validation and visualization placement. The medical doctor (md) did look, but did not cine the image. There was a post procedure chest x-ray that revealed that the proximal tip of the iabp was ¿seen on the inferior aspect of the aortic arch¿. This was taken 1. 5 hours prior to the ct. On arrival the patient appeared to be in acute renal failure (no prior known history with a creatinine (creat) of 3. 0) with elevation of his liver enzymes and elevated white blood cell count. There was no reported malfunction the device. The date of death was unknown.
 
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Brand NameUNKNOWN
Type of DeviceSYSTEM, 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 Key7374913
MDR Text Key103835401
Report Number2248146-2018-00206
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received02/28/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/27/2018 Patient Sequence Number: 1
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