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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 Air Leak (1008); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/15/2018
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, after the was inserted into the patient's body and the air in the balloon catheter was removed, the balloon catheter was inserted into the valve of the sheath, and air was attempted to be introduced through the side port of the sheath, however, air was continuously introduced during aspiration. Although the issue was resolved once, the air was continuously introduced through the side port again when the balloon catheter was advanced to the sheath by approximately. Therefore, it was considered as a hemostatic valve issue and the sheath was replaced. After the left superior pulmonary vein (lspv) ablation was completed, during left inferior pulmonary vein (lipv) ablation, a system notice was received indicating that the vacuum was disabled due to a problem with the coaxial umbilical cable. The procedure was continued by touching the "continue" button. During right inferior pulmonary vein (ripv) ablation, a system notice was received indicating a mechanical component error. After checking if the scavenging hose was bent, it was observed that the plug of scavenging facility was unlocked. In addition, as frost on the connector of the coaxial umbilical cable and balloon catheter was noted, the coaxial umbilical cable was replaced. Thereafter, during the second ripv ablation and the initial right superior pulmonary vein (rspv) ablation, the frost on the connector of the second coaxial umbilical cable and 2af284 balloon catheter was also noted. However, as no system notice was received, the procedure was continued and completed with cryo. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: data files showed that 10 applications were performed with a balloon catheter on the date of the event. System notices had occurred indicating that the vacuum was disabled due to a problem with the coaxial umbilical cable (#50001) and there was a mechanical component error. Also, the flow was fluctuating in multiple applications. Visual inspection of the sheath showed a shaft kink 2. 57 inches from the tip. The kink may have occurred post-procedure. Aspiration/flushing test did not show any air passing through the tube or expelled from the sheath distal tip. Multiple aspirations / injections were performed without air bubbles or leaks through the hemostasis valve when a test balloon catheter was introduced through the sheath. Hemostasis valve was leak tight. In conclusion, the sheath passed the performance test as per specification. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key7663817
MDR Text Key113289411
Report Number2184009-2018-00016
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 10/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number14072
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2018
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
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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