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

Model Number 2AF284

Device Problem Air Leak (1008)

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

Event Date 09/27/2017

Event Type  malfunction  

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, upon connecting the balloon catheter with the electrical umbilical cable and coaxial umbilical cable outside the patient's body, a system notice was received indicating that the safety system detected blood in the catheter handle, the injection was stopped and the vacuum disabled.The electrical cable was reconnected and the coaxial port was capped without resolve.Additionally, blood flowing through the balloon coaxial port was suspected.The balloon catheter and coaxial cable were then replaced, and test ablation outside of the patient's body was performed.The balloon catheter then temporarily deflated, and the ablation was stopped and restarted.Upon inserting the balloon catheter into the sheath, reflux of blood was aspirated through the side port of the sheath, and air was observed during aspiration.The balloon catheter was removed and re-inserted several times without resolve.The balloon catheter was then replaced with resolve.The case was completed with cryo.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device and data files were returned and analyzed.Data files showed that eleven injections were performed on the date of the event without any system notice triggered.The failure files did not show any system notice on the date of the event.Visual inspection of the balloon catheter showed that the device was intact with no apparent issues.Smart chip verification indicated that the catheter was used for five injections.The catheter passed the performance test; electrical integrity and impedance was within specification.The returned catheter passed the aspiration / flush test with a lab tested sheath.Dissection and pressure testing did not show any leaks or traces of liquid/blood inside the catheter.In conclusion, the reported air ingress issue and the system notice indicating that the safety system detected blood in the catheter handle, the injection was stopped and the vacuum disabled (#50006) were not confirmed through the data analysis or through the testing.The reported blood issue was not confirmed through testing or through data analysis.Also, the catheter passed the returned product inspection as per specification.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
• Type of Device: PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: 6957199
• MDR Text Key: 90432208
• Report Number: 3002648230-2017-00567
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100010/S015
• 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: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2018
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 62407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2017
• Initial Date FDA Received: 10/17/2017
• Supplement Dates Manufacturer Received: 11/03/2017
• Supplement Dates FDA Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2017
• 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 Age: 60 YR