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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 Air Leak (1008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/30/2017
Event Type  malfunction  
Manufacturer Narrative
Product event summary: the data files and sheath 4fc12, with lot 58317 were returned and analyzed. The data files showed one injection was performed with the catheter for the date of the event and no system notice was triggered. The data files also showed seven injections were performed with a different catheter. Visual inspection of the sheath showed the device was intact with no apparent issues. The sheath failed the performance test due to a leak at the hemostatic valve. Air aspiration was reproduced when a test balloon catheter was introduced through the sheath. Dissection showed the hemostatic valve was leaking; valve was torn. In conclusion, the reported issue was confirmed through testing but not through data analysis. The sheath failed the return product inspection due to a leaking hemostatic valve. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a cryo ablation procedure, air would continuously leak from the hemostatic valve of the sheath when advanced into the balloon catheter. The balloon catheter was replaced with resolve. The case was completed with cryo. This patient was a participant in the stop persistent af clinical study. No 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 Key6739231
MDR Text Key105783853
Report Number3002648230-2017-00381
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
Report Date 06/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/21/2019
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number58317
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/04/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2017
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: 07/24/2017 Patient Sequence Number: 1
Treatment
2AF284 CATHETER
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