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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 Appropriate Term/Code Not Available (3191)
Patient Problems Infarction, Cerebral (1771); Death (1802); Swelling (2091); Cardiac Tamponade (2226)
Event Date 09/08/2017
Event Type  Death  
Manufacturer Narrative
Medtronic was made aware of this event through a search of literature publications. It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events. This information is based entirely on journal literature. This event occurred outside the us. All information provided is included in this report. Patient information is limited due to confidentiality concerns. Of note, multiple patients/manufacturers/methods were noted in the article; however, a one to one correlation could not be made with manufacturers/methods/unique lot numbers. The model listed in the report is a representative of the model family, as there is no specific model listed. The baseline gender/age of the patients represented in the article is male/64 years old. Without a lot number or device serial number, the manufacturing date cannot be determined. Since no device id was provided, it is unknown if this event has been previously reported. The date of death is not available at the time of this report; as there is no indication of specific lot number/patient information. Referenced article: ¿management of cardiac tamponade in catheter ablation of atrial fibrillation: single-centre 15 year experience on 5222 procedures. ¿ europace (2017) 0, 1¿7. Doi:10. 1093/europace/eux307. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The literature publication reports the following patient complications while using a cryoablation balloon catheter/sheath catheter: there were reports of cardiac tamponade, shock, pericardial effusions, as a result of the ablation procedure. Treatment included pericardiocentesis with drains placed, blood infusions, and open chest surgery for two patients. There was one patient who experienced cardiac tamponade, was treated, and medication had been started on the first day post-procedure, and on the second day post-procedure. However, atrial fibrillation (af) recurred and was ¿resistant¿ to cardioversion. Then on the eighth day post-procedure, the patient had a cerebral infarction, but recovered within one week. There was also one patient who on the thirteenth day post-procedure, presented to the emergency room with chest discomfort, fever, ¿elevated inflammatory reaction,¿ with pericardial effusion, and ¿delayed¿ tamponade. Medication was given, and the effusion disappeared. However, the issue recurred as soon as the medication was stopped on the 36th day post-procedure, medication was given and gradually tapered off; which resolved the issue. In addition, there was one patient who died on the fourth day post-procedure, ¿related to the tamponade,¿ which according to the author was from ¿massive brain oedema. ¿ this patient, on the third say post-procedure, had a ¿brain stem infarction. ¿ medication had been started on the second post-procedural day. Of importance, for this patient, sinus rhythm was ¿maintained¿ after the procedure. Of note, multiple patients/manufacturers/methods were noted in the article; however, a one to one correlation could not be made with manufacturers/methods/unique lot numbers. The status/location of the catheters is unknown. 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 Key7138464
MDR Text Key95506874
Report Number3002648230-2017-00706
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 foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 12/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
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 Received11/27/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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: 12/21/2017 Patient Sequence Number: 1
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