MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP MEDTRONIC; FLEX CTH ADVANCE

Catalog Number 4FC12

Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Code Available (3191)

Event Date 12/12/2014

Event Type  malfunction  

Event Description

When the lasso catheter was withdrawn from the cryo-sheath, a sucking noise was identified and when aspiration was attempted from the cryo-sheath, there was a large volume of air within the sheath followed by blood.It was noted that when the patient took deep inspiratory cycles, the diaphragm was clearly malfunctioning and air was being sucked in through the diaphragm into the sheath.The physician placed his finger over the end of the diaphragm and successfully "tamponaded" the opening.The end of the cryo-balloon was then placed back through the diaphragm and the physician successfully "tamponaded" all the air influx, and then with aspiration, the air was removed.The electrophysiology technician then observed the same finding when the cryo-balloon was removed from the sheath.A whistling/sucking type noise was heard and there was clear inspiration of air through the diaphragm into the sheath with the patient's inspiration.Again, the diaphragm was occluded with the physician's finger and all air was then sucked back from the sheath.Throughout this space, fluoroscopy and cine were performed of the heart and no air entered the heart, and of course, it was noted that the sheath was in the right side at this time.This finding had not been noted on the left side.

• Brand Name: MEDTRONIC
• Type of Device: FLEX CTH ADVANCE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland, quebec H9H5 H3; CA H9H5H3
• MDR Report Key: 4408476
• MDR Text Key: 5166947
• Report Number: MW5040161
• Device Sequence Number: 1
• Product Code: LOX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Catalogue Number: 4FC12
• Device Lot Number: 48682
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8 FRENCH SHEATH; 4 FRENCH SHEATH; ARTIC FRONT ADVANCE 28MM CRYO-BALLOON; DECAPOLAR CATHETER; 5 FRENCH SHEATH; LASSO CATHETER; QUADRIPOLAR CATHETER; SHORT 16 FRENCH SHEATH
• Patient Age: 55 YR
• Patient Weight: 139