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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 Problem Hematoma (1884)
Event Date 01/01/2017
Event Type  Injury  
Manufacturer Narrative
Concomitant medical product: 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 baseline gender/age of the patients represented in the article is male/63 years old. The model listed in the report is a representative, 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. 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. Referenced article: ¿how safe are noacs compared with phenprocoumon after pulmonary vein isolation with the cryoballoon technique using purse-string suture closure?¿ int j cardiol (2017), http://dx. Doi. Org/10. 1016/j. Ijcard. 2017. 06. 077. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The literature publication reports the following patient complication while using a sheath catheter: multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers. There were nine (9) patients who experienced groin hematomas; three (3) were treated with transfusions and compression therapy; five (5) treated with compression therapy; and one (1) requiring surgical repair. The status/location of the sheath catheter 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 Key6801687
MDR Text Key82945926
Report Number3002648230-2017-00448
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
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 07/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2017
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 Received07/18/2017
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: 08/17/2017 Patient Sequence Number: 1
Treatment
ACHIEVE MAPPING CATHETER
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