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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 Death (1802); Low Blood Pressure/ Hypotension (1914)
Event Date 07/28/2020
Event Type  Death  
Manufacturer Narrative
Product event summary: the data files were returned and analyzed. The files showed at least five applications were performed with balloon catheter afapro28 with lot number 38648 without any issue on the date of the event. Clinical issues(hypotension and patient death) occurred following the procedure. In conclusion, the sheath was not returned for investigation. There is no indication of relation of the adverse event to the performance of the product. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that after a successful cryo ablation procedure, the patient was stable. It was further reported that a few hours after the procedure the patient's blood pressure dropped. Cardiopulmonary resuscitation was attempted but it was unsuccessful and the patient passed away.
 
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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 Key10413732
MDR Text Key203124965
Report Number3002648230-2020-00420
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeIT
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 08/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2020
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 Received07/29/2020
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: 08/17/2020 Patient Sequence Number: 1
Treatment
AFAPRO28 BALLOON CATHETER, 2ACH20 MAPPING CATHETER
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