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

Model Number 4FC12

Device Problem Difficult to Advance (2920)

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

Event Date 01/13/2016

Event Type  Injury  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Event Description

It was reported that during a cryoablation procedure, there was difficulty advancing the balloon catheter through the sheath valve upon the initial insertion.Once advanced through, there was no further product issue and the system was functioning within normal limits.It was further reported that during ablation of the right inferior pulmonary vein (ripv) the patient's blood pressure decreased and the ablation was stopped.Upon evaluation using intracardiac ultrasound, a pericardial effusion was noted.The effusion continued to grow.The balloon catheter was removed from the patient and the sheath was pulled back from the left atrium.Anticoagulation was reversed, and pericardiocentesis was performed.The case was aborted.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files for the date of the reported event and sheath, 4fc12 with lot 08496, were returned and analyzed.The data files did not show any system notices.Visual inspection of the sheath showed the shaft was kinked at multiple locations; 2.1 inches and 3.9 inches from the shaft, along with 0.1 inches from the handle.Air aspiration was produced when a test balloon catheter was introduced through the sheath.Dissection showed the hemostatic valve was leaking.A known clinical issue was encountered during the case.In conclusion, the reported compatibility issue was not confirmed through testing; however, the sheath, 4fc12 with lot 08496, failed the returned product inspection due to a leaking hemostatic valve.This product malfunction was found upon the manufacturer¿s investigation, separate from the initial known clinical issue encountered during the procedure.

Event Description

It was reported that during a cryoablation procedure, there was difficulty advancing the balloon catheter through the sheath valve upon the initial insertion.Once advanced through, there was no further product issue and the system was functioning within normal limits.It was further reported that during ablation of the right inferior pulmonary vein (ripv) the patientblood pressure decreased and the ablation was stopped.Upon evaluation using intracardiac ultrasound, a pericardial effusion was noted.The effusion continued to grow.The balloon catheter was removed from the patient and the sheath was pulled back from the left atrium.Anticoagulation was reversed, and pericardiocentesis was performed.The case was aborted.The sheath subsequently tested out of specification upon the manufactureranalysis.No further patient complications have been reported as a result of this event.

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 H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5381417
• MDR Text Key: 36467696
• Report Number: 3002648230-2016-00022
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/13/2016

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: 11/04/2017
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 08496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2016
• Initial Date FDA Received: 01/20/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 04/15/2016
• Supplement Dates FDA Received: 02/08/2016; 04/26/2016; 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2015
• 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): Hospitalization; Life Threatening; Required Intervention