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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Loss of consciousness (2418); Pericardial Effusion (3271)
Event Date 03/09/2017
Event Type  Injury  
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, the sheath was difficult to maneuver into the septum and a "twist" was suspected. Additionally, while trying to reach the right inferior pulmonary vein (ripv), the catheters dropped back into the right atria. Transeptal puncture was performed again and the catheters moved back into the left atria not allowing the sheath to be maneuvered. A dark area was observed at the shaft in fluoroscopy. The patient became unstable, dizzy, hypotensive, and lost consciousness. A pericardial effusion was confirmed. Pericardiocentesis was performed to drain the pericardia and the hospital stay was extended. The case was aborted and the patient was not under general anesthesia. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: clinical data files were received and reviewed. The files showed eight injections were performed with the balloon catheter. The sheath was returned and analyzed. Visual inspection of the sheath showed the shaft was kinked / twisted at 2. 3435 inches from the tip. Functional testing showed the deflection mechanism was working fine and the pull wire was not broken. However, the deflection at the tip of the shaft was out of plane due to the kink/twist. The sheath failed the inspection due to a shaft kink/twist near the tip.
 
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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 Key6455691
MDR Text Key105639815
Report Number3002648230-2017-00151
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeDA
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 03/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/07/2018
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number83522
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2016
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: 04/03/2017 Patient Sequence Number: 1
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