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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 Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)
Event Date 06/16/2020
Event Type  Death  
Manufacturer Narrative
Product event summary: the data files were returned and analyzed. The data files showed that seventeen applications were performed with the balloon catheter, 2af284 with lot 00437 without any issue on the date of the event. Clinical issues were encountered during the procedure. There is no relation of adverse event to the performance and malfunction of the product. The physical product was not returned for investigation. 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, a complication was noted by the anesthesia team. The patient's blood pressure dropped, cardiopulmonary resuscitation (cpr) was attempted, and was unsuccessful. The patient died. Incoming information indicated that the cause of death was cardiac tamponade.
 
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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 Key10263738
MDR Text Key198508126
Report Number3002648230-2020-00350
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2020
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 Received06/18/2020
Was Device Evaluated by Manufacturer? Yes
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: 07/13/2020 Patient Sequence Number: 1
Treatment
2AF284 BALLOON CATHETER, 990063-020 MAPPING CATHET
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