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

Model Number 4FC12

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 09/02/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the arctic front advance cryoablation catheter was used to isolate lspv, lipv, rspv and ripv sequentially.Treatment of ablation gap at the ripv was attempted using the freezor max cryoablation catheter but this approach was not successful and isolation was completed using a rf ablation catheter.The physician noticed under fluoroscopy that the cardiac motion had weakened.The patient was diagnosed with cardiac tamponade and pericardial effusion was drained by pericardial drainage catheter.The patient remained in stable condition.As per the physician, it is not clear at which point during the procedure that the cardiac tamponade had occurred.The patient was discharged from the hospital on (b)(6) 2014.Device 3 of 4, reference mfr report: 3002648230-2014-00156, 3002648230-2014-00157 and 3007798852-2014-00014.

Manufacturer Narrative

The device is not available for investigation; it was discarded after the procedure.There was no indication of product malfunction.Concomitant products: arctic front advance cardiac cryoablation catheter model 2af284, freezor max cardiac cryoablation catheter model 239f3, achieve mapping catheter model 990063-020.

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: 4126399
• MDR Text Key: 4950729
• Report Number: 3002648230-2014-00158
• 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: 09/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2015
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 37618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 00072 YR