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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUITY CATHETER GUIDE CATHETER

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ACUITY CATHETER GUIDE CATHETER Back to Search Results
Model Number 8115
Device Problems Human-Device Interface Problem (2949); Material Integrity Problem (2978)
Patient Problems Syncope (1610); Death (1802); Cardiac Tamponade (2226); Vascular Dissection (3160); Pericardial Effusion (3271)
Event Date 08/01/2018
Event Type  Death  
Manufacturer Narrative

The catheter was not expected to be returned. As no further information concerning this report is expected, our investigation is complete. This investigation will be updated should further information be provided.

 
Event Description

Boston scientific received information that while trying to access the coronary sinus with this catheter, a dissection occurred. The patient was syncopal and their blood pressure was very low. The physician identified a pericardial effusion and a preicardiocentesis was performed. The patient was intubated and stabilized. Only the right ventricular lead and device were implanted; no left ventricular lead was tried. No additional adverse patient effects were reported.

 
Event Description

Boston scientific received information that while trying to access the coronary sinus with this catheter, a dissection occurred. The patient was syncopal and their blood pressure was very low. The physician identified a pericardial effusion and a pericardiocentesis was performed. The patient was intubated and stabilized. Only the right ventricular lead and device were implanted; no left ventricular lead was tried. No additional adverse patient effects were reported. Boston scientific received additional information about this case. It was reported the physician had performed another pericardiocentesis later in the evening on the date of the implant procedure, but the patient subsequently died due to a cardiac tamponade. It was noted the physician had experienced some difficulty finding the coronary sinus and after the cs cannulation, there was some resistance introducing the delivery system. The implanted products were not explanted post-mortem.

 
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Brand NameACUITY CATHETER
Type of DeviceGUIDE CATHETER
Manufacturer Contact
timothy degroot
4100 hamline ave. n
st. paul, MN 55112
6515826168
MDR Report Key7826400
MDR Text Key118550506
Report Number2124215-2018-16575
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberK132914
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/29/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/23/2020
Device MODEL Number8115
Device LOT Number22162648
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location Hospital
Date Manufacturer Received08/09/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/29/2018 Patient Sequence Number: 1
Treatment
0292; G247
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