MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 4FC12

Device Problems Air Leak (1008); Defibrillation/Stimulation Problem (1573)

Patient Problems Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059); Ventricular Fibrillation (2130)

Event Date 11/06/2014

Event Type  Injury  

Event Description

During a cryoablation procedure, there was a drop in the patient's blood pressure.The physician noticed air bubbles in the line that connects the sheath to the heparinized saline bag; the nurse had just changed the flush bag to a new bag.St elevation occurred shortly after the air bubbles were noticed.Air embolism reported to have caused the st elevation which caused ventricular fibrillation (vf).Patient could not be shocked out of vf.Chest compressions were performed until patient stabilized (about 9 minutes).St elevation subsided and patient went into normal sinus rhythm.The cryoablation procedure was aborted.

Manufacturer Narrative

The device was not returned for investigation.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland,qc H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland,qc H9H 5 H3; CA H9H 5H3
• Manufacturer Contact: voula radiotis ; 16771 chemin ste-marie; kirkland,qc H9H 5-H3 ; CA H9H 5H3 ; 5146941212
• MDR Report Key: 4286599
• MDR Text Key: 16181320
• Report Number: 3002648230-2014-00207
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention