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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 Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)
Event Date 03/02/2021
Event Type  Injury  
Manufacturer Narrative
Product event summary: the data files were returned and analyzed. The files showed at least four applications were performed with a non-returned balloon catheter without any issue on the date of the event. In conclusion, the clinical issues (arterial puncture, bleed, hematoma) occurred following the procedure. The case was aborted under general anesthesia. There is no indication of relation of adverse event to the performance and malfunction of the product. The physical product was not returned. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that following a successful cryo ablation procedure, when the sheath was removed from the patient, oozing was noted. Groin pressure was maintained. The patient became unstable. A cardiac ultrasound was performed to exclude tamponade. Ultrasound of the groin showed pulsating blood flow into a hematoma. A femoral compression system was applied. It was concluded an arterial puncture or rupture had occurred. The patient was transferred to surgery for groin exploration and vascular closure and repair. 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 Key11542321
MDR Text Key241448262
Report Number3002648230-2021-00129
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeAS
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 03/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number0010460476
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 Received03/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/27/2020
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: 03/22/2021 Patient Sequence Number: 1
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