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

Model Number 990063-015

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/16/2014

Event Type  Injury  

Event Description

Medtronic received information of a cardiac tamponade that occurred during a cryoablation procedure.Two ablations were performed in right inferior pulmonary vein.Tamponade symptoms appeared when preparing to ablate the right superior pulmonary vein.The patient recovered following intervention.Patient has been discharged from the hospital without any further complications.Device 1 of 2, reference mfr report: 3002648230-2014-00224.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: ACHIEVE MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC ABLATION FRONTIERS; 2210 faraday ave ste 100 ; carlsbad CA 92008 7225
• 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: 4354247
• MDR Text Key: 5220874
• Report Number: 3007798852-2014-00024
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/26/2014

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: 05/04/2016
• Device Model Number: 990063-015
• Device Catalogue Number: 990063-015
• Device Lot Number: 0007139310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2014
• Initial Date FDA Received: 12/22/2014
• Supplement Dates Manufacturer Received: 11/26/2014
• Supplement Dates FDA Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2014
• 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: FLEXCATH STEERABLE SHEATH MODEL 3FC12
• Patient Outcome(s): Required Intervention