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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 Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513)
Event Date 06/11/2018
Event Type  Injury  
Manufacturer Narrative
Event summary: the returned patient data files showed at least six applications were performed with catheter 2af284/91556 on the date of event with no issue. Failure file did not show any system notice triggered on the event date. This is a clinical issue encountered during cryoablation procedure. Visual inspection of the sheath, 4fc12 / 04473, showed a deformation at the tip of the shaft. Functional testing of the sheath showed deflection worked as per specification. In conclusion, this is a clinical issue (bp, hr, hemorrhage, arrest) encountered during a cryoablation procedure. The sheath failed the returned product inspection due to a shaft tip deformation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that following a cryo ablation procedure, the sheath was in the process of being removed and the patients blood pressure and heart rate dropped significantly. Atropine was administered without resolve. The sheath was inserted back into the right ventricle and it was perforated. It was then indicated that cardiac arrest occurred. Cardiac massage was performed and percutaneous cardiopulmonary support (pcps) was attached to the patient to maintain circulatory dynamics. The bleeding was unable to be stopped and an emergency operation was performed and hemostasis was performed successfully. It was confirmed that the hemorrhage sites were on the right ventricle and around the left superior pulmonary vein (lspv) ostium of the left atrium. The case was already completed with cryo. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Incoming information received indicated that the patient had an extended hospitalization, and remains in the hospital with a stable condition at this time.
 
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 Key7655137
MDR Text Key112886442
Report Number3002648230-2018-00455
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 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number04473
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2018
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? Yes
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: 07/02/2018 Patient Sequence Number: 1
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