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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 Gas/Air Leak (2946)
Patient Problems Stroke/CVA (1770); Paralysis (1997); ST Segment Elevation (2059)
Event Date 08/24/2018
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, st elevation was observed by a left atrium angiography when the transseptal puncture was performed. It was then reported that air ingress occurred because air aspiration was not performed sufficiently after the dilator was removed. The case was completed with cryo. When the patient awoke, paralysis of the lower left extremities was noted. A magnetic resonance imaging (mri) and computerized tomography (ct) showed an acute stage cerebral infarction. The patient was transferred to the intensive care unit (icu) and an anti-platelet agent and medication for stroke recovery were administered. The patient underwent rehabilitation and recovered after three weeks of hospitalization. No further patient complications have been reported asa result of this event.
 
Manufacturer Narrative
Product event summary: the data files were returned and analyzed. The data files showed at least six applications were performed with balloon catheter, 2af284 with lot number 17148 on the date of the event without any issue. Clinical issues were encountered during the procedure. The sheath was not returned for investigation. There is no indication of relation of adverse event to the performance of the sheath. 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 Key7985636
MDR Text Key124390063
Report Number3002648230-2018-00742
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 11/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/24/2020
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number45103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/25/2018
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: 10/19/2018 Patient Sequence Number: 1
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