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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 Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/30/2016
Event Type  malfunction  
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, there was a loose hemostatic valve. The sheath was replaced and the procedure was completed with cryo. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the device, sheath 4fc12 with lot number 35710-74, was returned and analyzed. Visual inspection of the sheath showed the device was intact with no apparent issues. Multiple aspirations and injections were performed without air bubbles or leaks. The hemostatic valve was leak tight and the valve assembly was leak tight as well. In conclusion, the reported issue of possible loose hemostatic valve has not been confirmed through testing. The sheath passed the returned product inspection with no issues found.
 
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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 CRYOCATH LP
16771 chemin ste-marie
kirkland H9H 5 H3
CA H9H 5H3
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key5739865
MDR Text Key104822759
Report Number3002648230-2016-00245
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup
Report Date 05/30/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/22/2018
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number35710
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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