MAUDE Adverse Event Report: MDT ABLATION FRONTIERS MFG ACHIEVE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 990063-015

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Laceration(s) (1946); Pericardial Effusion (3271)

Event Date 01/28/2014

Event Type  Death  

Event Description

Information received by medtronic indicated that during a cryoablation procedure, a patient had a pericardial effusion and laceration in the lspv.After completing two 3-minute ablations in the lspv and allowing appropriate thaw time post balloon deflation, the cryoablation catheter, sheath and mapping catheter were positioned for ablation in the lipv.Prior to balloon inflation in the lipv, it was noted by the anesthesia personnel that there was a precipitous drop in blood pressure.The physician then moved the ultrasound catheter to better visualize the left ventricle.Once in position, a pericardial effusion was observed.The physician and his team took the appropriate measures to maintain hemodynamic stability while preparing the patient for a pericardiocentesis.Once this was completed, the patient's blood pressure responded appropriately, however large amounts of blood continued to drain into the collection bag.Due to the continued bleeding, the patient was taken to the operating room.Once in the or, the surgeon was able to find the cause of the bleeding; there was a laceration inside the lspv.The laceration was sewn closed by the surgeon and the patient was then transferred to the icu in stable condition.There were no product issues noted during the procedure.The case was aborted.Device 3 of 3, reference mfr report: 3002648230-2014-00028 and 3002648230-2014-00029.

Manufacturer Narrative

Visual inspection of the returned device showed that it was intact with no apparent issues.The mapping catheter passed the inspection as per specification.An internal capa has been initiated to investigate the risk of cardiac perforation, pericardial effusion and tamponade associated with cryoablation for atrial fibrillation.These are potential adverse events associated with cardiac catheter procedures and are listed in product technical manual.This report will be recorded and trended.

Event Description

Information received by medtronic indicated that during a cryoablation procedure, a patient had a pericardial effusion and laceration in the lspv.After completing two 3-minute ablations in the lspv and allowing appropriate thaw time post balloon deflation, the cryoablation catheter, sheath and mapping catheter were positioned for ablation in the lipv.Prior to balloon inflation in the lipv, it was noted by the anesthesia personnel that there was a precipitous drop in blood pressure.The physician then moved the ultrasound catheter to better visualize the left ventricle.Once in position, a pericardial effusion was observed.The physician and his team took the appropriate measures to maintain hemodynamic stability while preparing the patient for a pericardiocentesis.Once this was completed, the patient's blood pressure responded appropriately, however large amounts of blood continued to drain into the collection bag.Due to the continued bleeding, the patient was taken to the operating room.Once in the or, the surgeon was able to find the cause of the bleeding; there was a laceration inside the lspv.The laceration was sewn closed by the surgeon and the patient was then transferred to the icu in stable condition.There were no product issues noted during the procedure.The case was aborted.Additional information received 03/06/2014 indicated that the patient did not recover neurologically post surgical intervention.Date of death is unknown; date included above is best estimate.Device 3 of 3, reference mfr report: 3002648230-2014-00028 and 3002648230-2014-00029.

• Brand Name: ACHIEVE MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MDT ABLATION FRONTIERS MFG; 2210 faraday ave ste 100 ; carlsbad CA 92008 722
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland,qc H9H 5H3; CA H9H 5H3
• Manufacturer Contact: voula radiotis ; 16771 chemin ste-marie; kirkland,qc H9H 5-H3 ; CA H9H 5H3 ; 5146941212
• MDR Report Key: 3645396
• MDR Text Key: 4353971
• Report Number: 3007798852-2014-00003
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2015
• Device Model Number: 990063-015
• Device Catalogue Number: 990063-015
• Device Lot Number: 0006912097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2014
• Initial Date FDA Received: 02/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/01/2014
• 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 Sequence Number: 1
• Treatment: ARCTIC FRONT ADVANCE 2AF284,FLEXCATH ADVANCE 4FC12
• Patient Outcome(s): Death; Required Intervention