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

Model Number 2AF283

Device Problems Material Rupture (1546); Device Displays Incorrect Message (2591); Infusion or Flow Problem (2964)

Patient Problems Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914)

Event Date 07/16/2015

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.The device has not yet been analyzed.Results of evaluation of returned device will be submitted in a supplemental report.(b)(4).

Event Description

It was reported that during a cryo ablation procedure, error codes had occurred indicating a problem with the system.Also, the system detected fluid and blood in the catheter and stopped the injection and disabled the vacuum.Troubleshooting steps were provided and the case was continued.It was later noted that blood was visible in the coaxial cable and ruptured balloon observed.The patient was briefly hypotensive and had a short burst of atrial fibrillation (af) with a rapid heart rate, this resolved with cardioversion.The catheter and coaxial cable were replaced.The procedure was completed with cryo.The patient was under general anesthesia and no further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the product, balloon catheter 2af283 with lot number 89270-31, and data files were returned and analyzed.Data file analysis demonstrated system notice 50012, indicating that the refrigerant delivery path was obstructed, at the beginning of the first injection.At the fifth injection system notice 50005, indicating that the safety system detected fluid in the catheter and stopped the injection, occurred.Data files showed at least five injections were performed with the reported catheter.Visual inspection of the balloon catheter showed the device was stuck inside the flexcath advance sheath, 4fc12 with lot number 05964-23 (no complaints were received about the sheath), with both inner and outer balloon rupture as well as blood in the coaxial female connector.Verification of the smart chip file indicated the catheter was used for five injections.Both inner and outer balloons were ruptured around their equator.The distal end of the outer balloon was folded backwards.The distal and proximal end of the inner balloon appeared well attached to the shaft.The shaft of the catheter was kinked at 2.85 inches proximal from the tip.The catheter was dissected and blood was discovered in outer chamber, vacuum line and pressure sensor tube.The ruptured balloons appeared to be an inner balloon burst followed by an outer balloon breakage.In conclusion, the reported issues of 50005, a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection, 50006, a system notice was received indicating that the safety system detected blood in the catheter handle and the injection was stopped and the vacuum disabled, blood in coaxial umbilical and double balloon rupture, have been confirmed through testing and data analysis.Known inherent clinical adverse events occurred during procedure.Catheter 2af283 with lot number 89270-31 failed the returned product inspection due to a double balloon rupture and shaft kink.

Manufacturer Narrative

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; 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: 4988624
• MDR Text Key: 23860323
• Report Number: 3002648230-2015-00226
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Followup
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2017
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 89270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2015
• 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