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

Model Number 4FC12

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477); Pericardial Effusion (3271)

Event Date 01/14/2015

Event Type  Injury  

Manufacturer Narrative

The returned device was visually inspected and functionally tested.Visual inspection showed the shaft was kinked at 2.47 inches from the tip.The kink was preventing a smooth steerability when a cryoablation catheter was inserted.The kink was not reported as a complaint and it may have been caused post-procedure (e.G.Shipping back for analysis).

Event Description

Medtronic received information of a cardiac tamponade that occurred during a cryoablation procedure.The lspv, lipv, and rspv were successfully isolated.While manipulating the sheath/ablation catheter/mapping catheter system to the ripv, the system came across the atrial septum into the right atrium.The physician was able to successfully position the system back into the left atrium through the original transeptal puncture and enter the ripv.As ablation of the ripv was about to start, the anesthesiologist said the patient's pressure and oxygen saturations had significantly decreased.An echo was performed showing a pericardial effusion.A pericardiocentesis was performed, a little more than 1,200 ml of blood was removed.The patient's pressure initially increased, but dropped again after a few minutes.No further blood was able to be removed.Another echo was performed showing blood or clot against the right atrium/ventricle.Since the patient was still very symptomatic, a sub-xyphoid window was done to look for any fluid or clot.Some clot was found against the right side of the heart and removed.No other fluid was found and the bleeding had stopped.There was no sign of where the blood had come from.The patient stabilized.Chest tubes were placed and the patient was sent to the icu.Patient extubated and doing well the night of the event.Device 2 of 3, reference mfr report: 3002648230-2015-00030 and 3007798852-2015-00002.

Manufacturer Narrative

The device has not yet been analyzed.Results of evaluation of returned device will be submitted in a supplemental report.

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: 4508491
• MDR Text Key: 15673656
• Report Number: 3002648230-2015-00031
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 48685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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): Required Intervention
• Patient Age: 00074 YR