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

Model Number 4FC12

Device Problem Loss of Power (1475)

Patient Problems Death (1802); Vascular Dissection (3160); Pericardial Effusion (3271)

Event Date 11/07/2014

Event Type  Death  

Event Description

During a cryoablation procedure, the physician performed one ablation in the lspv followed by a normal thaw phase and balloon deflation.Before he could proceed with the next ablation in the lspv, there was a power outage in the lab and all equipment and fluoro went down for approximately 3 minutes until power was restored.The cryoconsole was restarted and after about 15-20 mins, fluoro was restored.The physician checked the position of the cryoablation catheter's balloon and checked the patient's vitals; confirmed everything was ok to proceed.Physician positioned balloon in the lspv and performed a second ablation.A normal thaw phase and balloon deflation followed.The physician waited another 10-15 seconds to allow balloon to fully warm, retracted the cryoablation catheter into the sheath to move it to the lipv.After about 2-3 minutes of trying to access the lipv, the anesthesiologist indicated that the patient had no pulse.The physician immediately checked for an effusion with an ice catheter and noticed a large effusion when imaging the left ventricle.Immediately began cpr on the patient and called ct surgery.After about an hour of trying to resuscitate the patient, the patient was pronounced dead.Ct surgeon concluded that the lspv was dissected.No product issues were noted during the procedure and no system notice messages occurred during the procedure.The medtronic representative was unable to collect the devices after the procedure and all product was discarded by staff.Device 2 of 3, reference mfr report: 3002648230-2014-00208 and 3007798852-2014-00022.

Manufacturer Narrative

The device is not available for investigation; it was discarded after the procedure.There was no indication of product malfunction.

Manufacturer Narrative

Corrected information: no eval explain code.

• 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: 4290122
• MDR Text Key: 5274626
• Report Number: 3002648230-2014-00209
• 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: 11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 11/07/2014
• 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
• Treatment: ARCTIC FRONT ADVANCE 2AF284, ACHIEVE 990063-020
• Patient Outcome(s): Death
• Patient Age: 00071 YR