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

Model Number 990063-020

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Infarction, Cerebral (1771)

Event Date 03/13/2015

Event Type  Injury  

Event Description

A cryoablation procedure was performed (b)(6) 2015.On the following day, the patient had cerebral infarction.The patient is recovering although his hands remained paralysed slightly.The physician considered that the patient would recover soon because the site of cerebral infarction was small.Device 3 of 3, reference mfr report: 3002648230-2015-00078 and 3002648230-2015-00079.

Event Description

A cryoablation procedure was performed (b)(6) 2015.On the following day, the patient had cerebral infarction.The patient is recovering although his hands remained paralysed slightly.The physician considered that the patient would recover soon because the site of cerebral infarction was small.Device 3 of 3, reference mfr report: 3002648230-2015-00080 and 3002648230-2015-00081.

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 avenue, suite 100; carlsbad CA 92008
• 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: 4688047
• MDR Text Key: 5670586
• Report Number: 3007798852-2015-00006
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 03/17/2015

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 Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2015
• Initial Date FDA Received: 04/14/2015
• Supplement Dates Manufacturer Received: Not provided; 03/17/2015
• Supplement Dates FDA Received: 04/14/2015; 09/29/2017
• 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,FLEXCATH ADVANCE 4FC12
• Patient Outcome(s): Other
• Patient Age: 00076 YR