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

Model Number 4FC12

Device Problem Insufficient Information (3190)

Patient Problem Pericardial Effusion (3271)

Event Date 10/22/2014

Event Type  Injury  

Event Description

Information received by medtronic indicated that a patient had a pericardial effusion during a cryoablation procedure on (b)(6) 2014.After brockenbrough method for transseptal catheterization, cti ablation was performed using a radiofrequency (rf) catheter.Pulmonary vein isolation was then performed using cryoablation.Cryoablation catheter, sheath and mapping catheter were inserted into left atria.Pulmonary vein isolation was carried out in order of ls, li, ri and rs.After confirmation of isolation, cardiac ultrasound performed and showed pericardial effusion.The pericardial effusion was suctioned by pericardial drainage (approximately 200cc).The pressure has been gradually backed to the normal range with time.Device 2 of 3, reference mfr report: 3002648230-2014-00199 and 3007798852-2014-00019.

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: 4255770
• MDR Text Key: 4993392
• Report Number: 3002648230-2014-00200
• 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,Followup
• Report Date: 10/22/2014

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: 07/01/2015
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 03771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2015
• Initial Date FDA Received: 11/17/2014
• Supplement Dates Manufacturer Received: Not provided; 02/23/2015
• Supplement Dates FDA Received: 02/25/2015; 09/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2014
• 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 (B)(4), ACHIEVE (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 00074 YR
• Patient Weight: 54