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

Model Number 4FC12

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

Patient Problems Chest Pain (1776); Fever (1858); Pleural Effusion (2010); ST Segment Elevation (2059); Pericardial Effusion (3271)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that post-operatively to a cryo ablation procedure, a small amount of pleural effusion in the left chest and pericardial effusion were confirmed.Additionally, the patient experienced chest pain and fever.The patient's hospitalization was extended three days.The patient took colchicine for one week.It was noted the patient had a fever and chest pain ten days after discharge.St elevation was identified by electrocardiogram (ecg).It was noted that the patient restarted taking colchicine and was under remission; the symptoms did not recur.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Event summary: the patient data files showed at least fourteen applications were performed with catheter 2af284/23281-31 on the date of event; some applications were non-sustained, application number nine had temperature problem, flow low profile and fluctuation.Clinical issues (chest pain, fever, pericardial effusion) were encountered during the procedure and st elevation confirmed after one week.No product was returned for investigation.In conclusion, clinical issues (chest pain, fever, pericardial effusion and st elevation) were encountered during the procedure and post procedure.No indication of product malfunction.The sheath was not returned for investigation.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; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6714087
• MDR Text Key: 80051933
• Report Number: 3002648230-2017-00362
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2017
• 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: 990063 MAPPING CATHETER, 2AF284 BALLOON CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR