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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 Problem Transient Ischemic Attack (2109)
Event Date 10/08/2020
Event Type  Injury  
Manufacturer Narrative
Product event summary: the data files were returned and analyzed. The data files showed at least eight applications were performed with afapro28 balloon catheter with an unknown lot number without any issue on the date of the event. In conclusion, the reported transient ischemic attack (tia) and leg movement difficulty occurred after the procedure. There is no indication that the adverse events are related to the performance or a malfunction of the product. 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 patient had a transient ischemic attack (tia). The patient had difficulty moving their leg, which later improved. The patient's hospitalization stay was extended. 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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10785916
MDR Text Key214581352
Report Number3002648230-2020-00570
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeIS
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
Report Date 11/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot NumberUNKNOWN
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 Received10/09/2020
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: 11/04/2020 Patient Sequence Number: 1
Treatment
AFAPRO28 BALLOON CATHETER, 2ACH20 MAPPING CATHETER
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