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

Model Number 4FC12

Device Problems Difficult to Insert (1316); Difficult to Advance (2920)

Patient Problems Vomiting (2144); Cardiac Tamponade (2226)

Event Date 11/06/2014

Event Type  Injury  

Event Description

Medtronic received information of a cardiac tamponade.Physician reported that after puncturing the septum using a rf needle, the sheath was advanced to the pulmonary vein with difficulty.The physician commented that there was gap between the sheath and the catheter that was preventing the smooth insertion of the sheath.Cryoablation procedure was performed with one ablation each to the lspv, lipv and rspv and two ablations to the ripv.Sheath were removed from left atrium and cti ablation was performed using a rf catheter.The patient vomited during rf ablation procedure.Cardiac tamponade diagnosed and epicardial needle drainage was performed immediately.Physician suspects that the cardiac tamponade was related to the sheath.

Manufacturer Narrative

Investigation was not possible since the device was not returned; it was discarded by the user facility.

Event Description

Medtronic received information of a cardiac tamponade.Physician reported that after puncturing the septum using a rf needle, the sheath was advanced to the pulmonary vein with difficulty.The physician commented that there was gap between the sheath and the catheter that was preventing the smooth insertion of the sheath.Cryoablation procedure was performed with one ablation each to the lspv, lipv and rspv and two ablations to the ripv.Sheath were removed from left atrium and cti ablation was performed using a rf catheter.The patient vomited during rf ablation procedure.Pericardial effusion was diagnosed by echocardiogram and epicardial needle drainage (300 ml) was performed immediately.Physician suspects that the cardiac tamponade was related to the sheath.There were no patient complications at the end of the procedure and patient discharged on (b)(6) 2014.

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: 4286157
• MDR Text Key: 5082459
• Report Number: 3002648230-2014-00206
• 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: 11/06/2014

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?: Yes
• 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: 12/04/2014
• Initial Date FDA Received: 12/01/2014
• Supplement Dates Manufacturer Received: Not provided; 12/04/2014
• Supplement Dates FDA Received: 12/05/2014; 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
• Patient Outcome(s): Required Intervention