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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 Problems Gas Leak (2946); Appropriate Term/Code Not Available (3191)
Patient Problem Air Embolism (1697)
Event Date 06/01/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: arctic front advance cardiac cryoablation catheter. Medtronic was made aware of this event through a search of literature publications. It was not possible to ascertain specific patient or 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. The model listed in the report is a representative of the model family, as there is no specific model listed. Multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers. The baseline gender/age of the patients represented in the article is male/62 years old. Without a lot number or device serial number, the manufacturing date cannot be determined. Referenced article: ¿silent cerebral events/lesions after second-generation cryoballoon ablation ~ how can we reduce the risk of silent strokes?¿ heart rhythm (2018), doi:10. 1016/j. Hrthm. 2018. 07. 011. 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 cryoballoon ablation catheter system: there were patients who had asymptomatic silent cerebral lesions/silent cerebral embolic events detected during the ablation procedure. There were also patients with ¿transient¿ st elevations. There was also a mention of a ¿product misuse¿ massaging balloon technique that may have been used; however, there was no indication of patient injury. The article reports that there were no complications. The status/location of the system is unknown. Additional information was obtained from follow up with the physician/author who indicated that the issues were related to the products, and that the products were discarded; therefore, no lot numbers are available. Also, the physician reported that there were no injuries due to the ¿balloon massage. ¿ no further information was provided.
 
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 Key7806662
MDR Text Key117914960
Report Number3002648230-2018-00564
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,Followup
Report Date 08/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received07/23/2018
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: 08/22/2018 Patient Sequence Number: 1
Treatment
ACHIEVE MAPPING CATHETER
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