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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE

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MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE Back to Search Results
Model Number 4FC12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiopulmonary Arrest (1765); Loss of consciousness (2418); Cardiac Perforation (2513); Pericardial Effusion (3271)
Event Date 11/20/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was further reported that the patient was found to be unresponsive to name, and remained unresponsive. Therefore, an echo, drain, and subsequent surgical intervention were performed. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a cryo ablation procedure, the transseptal puncture was performed with a competitor device and exchanged for the sheath. Prior to the first inflation with the sheath and balloon catheter in the heart, it was noted that the left heart border did not appear to be moving on the x ray. Imaging was preformed again and the heart border appeared to be moving. A fluorograph and echocardiogram were performed after the patient was given cardiopulmonary resuscitation (cpr) and a pericardial effusion was observed. The physician requested blood and the anesthesiologist. A sternotomy was performed and the patient was found to have a small hole on the ridge between the left atrial appendage and the left superior pulmonary vein. The procedure was aborted. Surgical intervention was performed successfully and the patient was stabilized. It was later noted by the physician that the trans-septal puncture was "clean" and there was a possibility that the tear was caused by the competitor guidewire but the physician was not sure. No further patient complications have been reported as a result of this event.
 
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Brand NameFLEXCATH ADVANCE STEERABLE SHEATH
Type of DeviceCATHETER, STEERABLE
Manufacturer (Section D)
MEDTRONIC CRYOCATH LP
9000 autoroute transcanadienne
pointe-claire,qc H9R 5 Z8
CA H9R 5Z8
Manufacturer (Section G)
MEDTRONIC CRYOCATH LP
9000 autoroute transcanadienne
pointe-claire,qc H9R 5 Z8
CA H9R 5Z8
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7067780
MDR Text Key105826510
Report Number3002648230-2017-00648
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K123591
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 01/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/08/2019
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number69979
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 Received01/03/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/08/2017
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: 11/29/2017 Patient Sequence Number: 1
Treatment
990063-20 MAPPING CATHETER
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