MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP COAXIAL UMBILICAL CABLE

Model Number 203CX

Device Problems Device Contamination with Body Fluid (2317); Device Displays Incorrect Message (2591); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/12/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).

Event Description

It was reported that during a cryo ablation procedure, two system notices were displayed indicating the safety system detected fluid in the catheter and stopped the injection and the safety system detected blood in the catheter handle, the injection was stopped and the vacuum disabled.Blood was also reported to be visible in the catheter and coaxial umbilical cable connector.The catheter was replaced but the procedure was completed with radiofrequency.No 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 the coaxial umbilical cable, 203cx with an unknown lot, were returned and analyzed.The data files confirmed the reported 50005 system notice indicating ¿leak detection¿, and the reported 50006 system notice indicating ¿blood detection¿.It was noted that the data files also showed two system notices unrelated to the reported issue.Visual inspection of the coaxial umbilical cable showed traces of blood on the coaxial connector and within the vacuum tube and the injection line.In conclusion, the reported 50005 and 50006 system notices were confirmed through testing and through data analysis.The coaxial umbilical cable, 203cx with an unknown lot, failed the visual inspection due to the presence of blood in the vacuum and injection lines.

Manufacturer Narrative

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

• Brand Name: COAXIAL UMBILICAL CABLE
• Type of Device: CABLE
• 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: 5418751
• MDR Text Key: 38584510
• Report Number: 3002648230-2016-00037
• Device Sequence Number: 1
• Product Code: ISN
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P020045
• 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: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 203CX
• Device Catalogue Number: 203CX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2016
• 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: Unknown
• Patient Sequence Number: 1