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

Model Number 4FC12

Device Problem Air Leak (1008)

Patient Problems Air Embolism (1697); Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059)

Event Date 05/10/2018

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, when a competitor mapping catheter was inserted into the sheath, st elevation occurred, and the patient complained of chest pain and blood pressure declined.Nitroglycerin and neosynesine were administered were administered.It was noted that there possibly was an air embolism.Noradrenalin and neosynesine were administered.No air was observed through fluoroscopy, and a coronary angiography (cag) showed there was no stenosis.The case was completed with cryo.The following day post procedure, mri confirmed there were not any issues with the patient.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: data files returned and analyzed.Data files showed that 10 applications were performed with a balloon catheter on the date of the event.A system notice had occurred indicating that the refrigerant delivery path was obstructed (#50012).In conclusion, a clinical issue occurred during the case and there was no indication of a product performance issue with the balloon catheter.The device was not returned for analysis/investigation.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: 7575355
• MDR Text Key: 110287699
• Report Number: 3002648230-2018-00368
• 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: 09/05/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 08/10/2018
• Supplement Dates FDA Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: No
• 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; Required Intervention
• Patient Age: 77 YR