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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 Problems Air Embolism (1697); Stroke/CVA (1770); Death (1802); Embolism (1829); ST Segment Elevation (2059); Confusion/ Disorientation (2553)
Event Date 07/18/2017
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was further reported that the cause of death was a cerebral hemorrhage.
 
Manufacturer Narrative
Product event summary: the sheath, 4fc12 with lot number 48894 was returned and analyzed. Visual inspection of the sheath showed the device was intact with no apparent issues. Air aspiration was reproduced when a test balloon catheter was introduced through the sheath. Dissection showed the hemostatic valve was leaking and it was torn. In conclusion, the reported air ingress issue was confirmed through testing. The sheath failed the returned product inspection due to a leaking hemostatic valve. Also, a clinical issue (embolism) was encountered and it was not confirmed through testing. 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.
 
Event Description
(b)(6) 2018: incoming information indicated that the patient had died following the case. Further details are unknown at this time.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was further reported that the patient experienced st elevation, an air embolism and disoriented. Also, it was noted that the cerebral hemorrhage was due to the patient's condition. As the patient had an uncontrolled inr from an anticoagulation regimen.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a cryoablation procedure, air ingress occurred during aspiration and resulted in a coronary embolism. The case was aborted while the patient was under general anesthesia. The patient was sent to another hospital for special surveillance regarding potential brain embolism. The patient¿s hospitalization was extended two days. 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 Key6770362
MDR Text Key105785453
Report Number3002648230-2017-00426
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeFR
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,Followup,Followup
Report Date 06/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/05/2019
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number48894
Was Device Available for Evaluation? No
Date Returned to Manufacturer08/09/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/05/2017
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: 08/07/2017 Patient Sequence Number: 1
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