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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. AUTOCAT 2 WAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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ARROW INTERNATIONAL, INC. AUTOCAT 2 WAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number AUTOCAT 2 WAVE
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Cardiac Arrest (1762); Endocarditis (1834); High Blood Pressure/ Hypertension (1908); Mitral Regurgitation (1964); Pulmonary Edema (2020); Stenosis (2263); No Code Available (3191)
Event Date 06/21/2017
Event Type  malfunction  
Event Description
The patient was admitted approximately one month ago and stayed in hospital for seven days. The plan was to transfer her to another hospital for intervention. Per md notes prior to transfer: status postintra-aortic balloon pump ppd 1. Status post left hear catheterization with mid left anterior descending 70% stenosis ppd1. Secondary pulmonary hypertension group 2 (mitral valve) and group 3 (copd) with pulmonary edema 2/2 severe mitral regurgitation; pulmonary artery systolic pressure (pasp) 80mmhg. Possible infective endocarditis vs fat pad seen on transesophageal echocardiography (tee). Cardiogenic shock 2/2 severe mitral regurgitation; tte with ejection fraction (ef) 60-65% status post cardiac arrest, epinephrine x 1 with return of spontaneous circulation (rosc). Ventilator-dependent respiratory failure status post arrest. Copd. Approximately three weeks ago patient was transported to another hospital. Balloon pump shut down during transport as team was walking through er to patient room. Per report: no battery life at all. Pump was continuously plugged in prior to transport. Patient was not affected & bp remained stable. Team was able to hook up patient to receiving hospital's iabp. Manufacturer response for intra-aortic balloon pump, (brand not provided) (per site reporter): clinical engineering waiting for parts from manufacturer.
 
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Brand NameAUTOCAT 2 WAVE
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
ARROW INTERNATIONAL, INC.
16 elizabeth dr
chelmsford MA 01824
MDR Report Key6773572
MDR Text Key82042535
Report Number6773572
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 07/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAUTOCAT 2 WAVE
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/13/2017
Event Location Hospital
Date Report to Manufacturer07/13/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/08/2017 Patient Sequence Number: 1
Treatment
NO OTHER THERAPIES; PATIENT IS VENTILATOR-DEPENDENT
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