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

Model Number 4FC12

Device Problems Fluid/Blood Leak (1250); Gas/Air Leak (2946)

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762); Embolism (1829); Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059); Ventricular Fibrillation (2130)

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, after the dilator of the sheath was removed, st elevation occurred.A coronary angiography was performed and showed that an air embolism had developed.Aspiration was performed with a competitor air suction catheter and intra aortic balloon pump.It was observed with an angiography and fluoroscopy.It was noted that during aspiration, cardiac arrest and ventricular fibrillation (vf) occurred three times and the patient was hypotensive.The patient recovered two hours after leaving the catheter lab.The case was aborted and it was noted that the patient was not under general anesthesia.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the sheath was returned and analyzed.Visual inspection of reported sheath 4fc12 lot number 72813 showed the device was intact with no apparent issues.Flushing and air aspiration testing did not show any air passing through the tube or expelled from the distal tip.However, functional testing of the sheath confirmed the hemostatic valve was leaking.Air bubbles were observed through the valve, and it was suspected that the valve disk is torn.In conclusion, the reported air ingress issue was confirmed through product testing.The clinical issues (cardiac arrest, air embolism, st elevation, hypotension, ventricular fibrillation, and aborted under general anesthesia) that were encountered during the case were not confirmed through product testing.The reported sheath failed the returned product inspection due to a leaking hemostatic valve.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed that at least 25 applications were performed with balloon catheter 2af284 with lot number 22188 on the date of the event.Unrelated system notice #50012 ¿the refrigerant delivery path is obstructed¿ was triggered on first and second ablations.The data files showed at least two more applications were performed with non-returned catheter 238f5 with lot number 95745 without any issue on the date of the event.The reported air ingress issue could not be assessed through data analysis.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; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8056253
• MDR Text Key: 126705656
• Report Number: 3002648230-2018-00797
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/11/2019

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 Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 72813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2018
• Initial Date FDA Received: 11/09/2018
• Supplement Dates Manufacturer Received: 11/27/2018; 12/27/2018; 01/14/2019
• Supplement Dates FDA Received: 12/18/2018; 12/27/2018; 02/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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): Life Threatening