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

Model Number 4FC12

Device Problems Inflation Problem (1310); Activation, Positioning or Separation Problem (2906)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 10/30/2014

Event Type  Injury  

Event Description

Medtronic received information of a pericardial effusion.The transseptal atrial puncture was performed using a rf needle and the guide wire was inserted to left atrium (la) through the foramen ovale.The physician reported difficulty/resistance inserting a transeptal introducer through the foramen ovale.The flexcath advance sheath was then inserted.Following fluoroscopy and lesion geometries at la and pulmonary veins, the arctic front advance cryoablation catheter and achieve mapping catheter were inserted in the flexcath advance sheath and placed at the lspv.There were issues during inflation of the balloon of the cryoablation catheter; the balloon was not sufficiently inflated for ablation and the physician removed the catheter to replace it with another arctic front advance catheter.When the new catheter was prepared, the pv fluoroscopy was reviewed and found that the slight amount of dye was leaking out of the blood vessel area (epicardium).Intacardiac echography showed possible accumulation of pericardial effusion and the procedure was stopped.The patient's health care providers reported that the patient's blood pressure decreased and 600cc of fluid was aspirated.The patient is expected to be hospitalized more than one week.Device 2 of 3, reference mfr report: 3002648230-2014-00202 and 3007798852-2014-00021.

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: 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: 4276774
• MDR Text Key: 16543955
• Report Number: 3002648230-2014-00203
• 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: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2015
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 92077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2014
• 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: ARCTIC FRONT ADVANCE 2AF284, ACHIEVE 990063-020
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00059 YR