MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ARTIC FRONT ADVANCE SHORT TIP CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number 2AFAST28

Device Problem Application Program Version or Upgrade Problem (2881)

Patient Problems Low Blood Pressure/ Hypotension (1914); Idioventricular Rhythm (1923)

Event Date 01/22/2016

Event Type  Injury  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Event Description

It was reported that during a cryo ablation procedure, a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection.Also, it was reported that there was a double balloon breach of the catheter.The patient experienced hypotension and a ventricular heart rhythm.It was noted that the patient stabilized after supportive measures and the nitrous oxide dissipated as the patient recovered.The balloon catheter was removed and replaced.The procedure was completed with the cryo console.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the balloon catheter and data files were returned and analyzed.The data files confirmed the system notices that indicated that the safety system detected fluid in the catheter and stopped the injection (50005) and a compromised outer vacuum was detected simultaneously at application six.Also, six applications were performed using the catheter.Furthermore, the data files showed a high baseline flow at the beginning of the inflation.Visual inspection of the catheter showed that the device was full of blood.The inner and outer balloons were ruptured around the equator.Also, the distal ends of the balloons were folded backwards.There was a kink at the tip that induced while trying to clear the tip and the guide wire lumen material was extremely soft.The proximal bonding outside diameter (od) was within specification.The catheter shaft was kinked at two locations.The first kink was 2.12 inches distal from the strain relief.The second kink was 1.5 inches proximal from the distal shaft.Also, the smart chip verification indicated that the catheter was used for six injections.The guide wire lumen was pressurized and no breach of the guide wire lumen was observed.In conclusion, the reported issue was confirmed through testing and through data analysis.The catheter failed the visual inspection due to double balloon rupture, guide wire lumen pinch and shaft kink.Performance testing and failure analysis were not conducted due to the condition of the catheter.

Manufacturer Narrative

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

• Brand Name: ARTIC FRONT ADVANCE SHORT TIP CARDIAC CRYOABLATION CATHETER
• Type of Device: PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: 5410215
• MDR Text Key: 37464416
• Report Number: 3002648230-2016-00032
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100010 S046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2017
• Device Model Number: 2AFAST28
• Device Catalogue Number: 2AFAST28
• Device Lot Number: 57551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2015
• 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: 00062 YR
• Patient Weight: 102