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

Model Number 4FC12

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982); Visual Disturbances (2140); Dizziness (2194); Numbness (2415); Ambulation Difficulties (2544)

Event Date 03/20/2014

Event Type  Injury  

Event Description

Information received by medtronic describing adverse events that occurred following a successful pulmonary vein isolation procedure on (b)(6) 2014 using the sheath with phased rf catheters.(b)(6) 2014: patient hospitalized due to pericarditis.Rub auscultated; sharp, pleuritic chest pain, improved with leaning forward.Patient treated with 50mg oral indomethacin and pain resolved (b)(6) 2014.Patient discharged (b)(6) 2014.(b)(6) 2014: patient experienced dizziness and trouble keeping balance the evening after discharge from the hospital.Resolved (b)(6) 2014; the same day that patient stopped taking indocin.(b)(6) 2014: patient developed double vision and intermittent numbness on right side of face the day after discharge.Resolved (b)(6) 2014; the same day that patient stopped taking indocin.Mri performed on patient during week of (b)(6) 2014; there were no intracranial abnormalities identified.

Manufacturer Narrative

The device was not returned for investigation.There was no indication of product malfunction.

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: 3757092
• MDR Text Key: 15322014
• Report Number: 3002648230-2014-00071
• 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: Study,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2015
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 78481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/30/2014
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 00051 YR
• Patient Weight: 124