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

Model Number 4FC12

Device Problem Air Leak (1008)

Patient Problem Air Embolism (1697)

Event Date 09/08/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.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 four pulmonary veins were ablated, the balloon catheter was extracted from the sheath and the mapping catheter was inserted.During insertion of the mapping catheter, when a reflux of blood was aspirated from the sheath, air ingress was confirmed.As the patient snored loudly at that moment, it was considered that due to the negative pressure inside the thoracic cavity.An oxygen mask was used with resolve.The mapping catheter was then removed from the sheath and the balloon catheter was re- inserted.Once the balloon catheter was inflated, fluoroscopy confirmed air.The air was then aspirated with resolve.Touch up was performed using radiofrequency and the case was completed.It was suggested that the an air embolism was present.An magnetic resonance imaging (mri) was performed and an embolism was unable to be confirmed.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Event summary: the patient data files showed at least thirty-seven applications were performed with catheter 2af284 / 62270-69 without any system notices on the date of event.Several applications were noticed with this catheter during which the inflation was not sustained.The flexcath advance sheath 4fc12/ 14898 was not returned.A clinical issue occurred during the case (air embolism).In conclusion, the reported air ingress issue cannot be confirmed through data analysis.A clinical issue occurred during the case (air embolism).The sheath was not returned.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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6910401
• MDR Text Key: 88005709
• Report Number: 3002648230-2017-00546
• 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
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 14898
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2017
• 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