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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 Problems Difficult To Position (1467); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pericardial Effusion (3271)
Event Date 02/17/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. (b)(4).
 
Event Description
It was reported that during a cryo ablation procedure, the physician noticed pericardial fluid in the pericardial sac via an intracardiac echo (ice) image. It was further reported that the patient underwent a pericardiocentesis procedure to remove three hundred and forty five milliliters of fluid and heparin was reversed. It was noted that the patient was stable prior to leaving the operating room. The physician reported being unsure which product caused the perforation, but stated that the placement of the sheath was difficult when crossing the septum. The case was completed with cryo. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the data files for the date of the reported event were returned and analyzed; no system notices were recorded. No product malfunction was reported, and no product was returned for investigation. A known clinical issue was encountered during the procedure.
 
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Brand NameFLEXCATH ADVANCE STEERABLE SHEATH
Type of DeviceCATHETER, STEERABLE
Manufacturer (Section D)
MEDTRONIC CRYOCATH LP
16771 chemin ste-marie
kirkland H9H 5 H3
CA H9H 5H3
Manufacturer (Section G)
MEDTRONIC CARDIAC RHYTHM HEART FAILURE
8200 coral sea st ne
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key5479916
MDR Text Key104701465
Report Number3002648230-2016-00078
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/30/2017
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number47376
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 Received04/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2015
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: 03/04/2016 Patient Sequence Number: 1
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