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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MICROSNARE CATHETER, PERCUTANEOUS

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COVIDIEN MICROSNARE CATHETER, PERCUTANEOUS Back to Search Results
Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Scratched Material (3020); Physical Resistance/Sticking (4012)
Patient Problems Death (1802); Necrosis (1971); Occlusion (1984)
Event Date 11/08/2017
Event Type  Death  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

The physician used a microsnare device to capture a corevalve evolut r (29mm diameter) implanted the day before. While retrieving the valve with the snare device, a new non-medtronic valve was implanted. The physician tried to retrieve the snare device, but the device caught on the paddle of the corevalve evolut r and could not be separated. The physician then used a biopsy forceps to grasp the snare device to separate it from the paddle and the device was removed from the patient. Following this, it was suspected the patient developed occlusion in the left occipital lobe, renal artery and coeliac artery. Using ct imaging, the patient was diagnosed with intestinal necrosis caused by occlusion of the coeliac artery with progression of acidosis and elevation of lactate confirmed. Nad and vasopressin were administered. It was reported that it was becoming difficult to maintain the patient¿s blood pressure and there was a decline in their heart rate and blood pressure. The patient lost spontaneous respiration and died two days post procedure. An autopsy was not performed but the cause of the death was confirmed as intestinal necrosis. The physician commented regarding the thromboembolism that it was considered that the occlusion was caused by the vascular wall being scratched while dragging the valve with the snare device.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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Brand NameMICROSNARE
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key7701811
MDR Text Key114403600
Report Number2183870-2018-00385
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK925439
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 10/04/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/19/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
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 Initial

Patient TREATMENT DATA
Date Received: 07/19/2018 Patient Sequence Number: 1
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